<p>/PRNewswire/ -- 奥林巴斯公司今天宣布对其一次性结扎装置（&#34;PolyLoop&#34;）进行自愿的医疗器械纠正措施，因发现潜在的安全问题。</p>
<p>PolyLoop 装置旨在与奥林巴斯内窥镜配合使用，提供一种尼龙环套索，旨在防止或控制在切除带蒂息肉后出现的出血。</p>
<p>奥林巴斯在收到不良事件报告后采取了这一措施，报告指出 PolyLoop 在使用过程中可能未能按预期释放或脱离，导致环意外地固定在患者的解剖结构上。目前尚未报告死亡案例。</p>
<p>未释放的结扎环可能会带来程序性挑战，需要紧急干预以从患者的解剖结构中移除。风险包括出血、黏膜损伤、穿孔，以及在严重情况下需要外科干预或住院治疗。</p>
<p>客户在 2025 年 11 月通过信件被通知了纠正措施，并被要求确保所有人员熟悉补充说明指导和现有的警告与注意事项，包括使用说明中概述的紧急处理程序。美国的客户被要求通过访问奥林巴斯召回网页并输入召回编号 &#34;0476&#34; 来确认收到信件：https://olympusamerica.com/recall。</p>
<p>使用该产品时遇到的不良反应或质量问题可以在线报告给 FDA 的 MedWatch 程序：https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda。</p>
<p>如需信息或报告设备问题，请联系奥林巴斯技术支持中心，电话：1-800-848-9024，选项 1，或发送电子邮件至 [email protected]。</p>
<p>来源：奥林巴斯公司</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjA1Jk5ld3NJdGVtSWQ9UEg0MDY1OSZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMDUxNjAwUFJfTkVXU19VU1BSX19fX19QSDQwNjU5?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjA1Jk5ld3NJdGVtSWQ9UEg0MDY1OSZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMDUxNjAwUFJfTkVXU19VU1BSX19fX19QSDQwNjU5"/></p>

奥林巴斯

<p>奥林巴斯公司已宣布对其一次性结扎装置 “PolyLoop” 采取自愿纠正措施，原因是存在潜在的安全问题。该装置可能无法按预期释放，可能导致出血和粘膜损伤等风险。客户在 2025 年 11 月已被通知，并被建议遵循更新的指导并向 FDA 的 MedWatch 项目报告任何问题。目前尚未报告任何死亡案例</p>

<p>, /PRNewswire/ -- Olympus Corporation today announced a voluntary medical device corrective action for its Single-Use Ligating Device (&#34;PolyLoop&#34;) following identification of a potential safety issue.</p>
<div class="lb-trans"><p>/PRNewswire/ -- 奥林巴斯公司今天宣布对其一次性结扎装置（&#34;PolyLoop&#34;）进行自愿的医疗器械纠正措施，因发现潜在的安全问题。</p>
</div><p>The PolyLoop device is designed for use with Olympus endoscopes to deliver a nylon loop snare intended to prevent or control bleeding following polypectomy of pedunculated polyps.</p>
<div class="lb-trans"><p>PolyLoop 装置旨在与奥林巴斯内窥镜配合使用，提供一种尼龙环套索，旨在防止或控制在切除带蒂息肉后出现的出血。</p>
</div><p>Olympus took this action after receiving adverse event reports indicating that the PolyLoop may fail to release or detach as expected during use, resulting in the loop becoming unintentionally anchored around patient anatomy. No deaths have been reported.</p>
<div class="lb-trans"><p>奥林巴斯在收到不良事件报告后采取了这一措施，报告指出 PolyLoop 在使用过程中可能未能按预期释放或脱离，导致环意外地固定在患者的解剖结构上。目前尚未报告死亡案例。</p>
</div><p>An unreleased ligation loop can present procedural challenges, requiring emergency intervention for removal from patient's anatomy. Risks include bleeding, mucosal injury, perforation, and in severe cases, the need for surgical intervention or hospitalization.</p>
<div class="lb-trans"><p>未释放的结扎环可能会带来程序性挑战，需要紧急干预以从患者的解剖结构中移除。风险包括出血、黏膜损伤、穿孔，以及在严重情况下需要外科干预或住院治疗。</p>
</div><p>Customers were notified of the corrective action by letter in November 2025 and are asked to ensure all personnel are familiar with the supplemental illustrative guidance and existing warnings and cautions, including the emergency treatment procedure outlined in the Instructions for Use. Customers in the U.S. are asked to acknowledge receipt of the letter on the Olympus recall web portal by visiting: https://olympusamerica.com/recall and entering the recall number &#34;0476&#34;.</p>
<div class="lb-trans"><p>客户在 2025 年 11 月通过信件被通知了纠正措施，并被要求确保所有人员熟悉补充说明指导和现有的警告与注意事项，包括使用说明中概述的紧急处理程序。美国的客户被要求通过访问奥林巴斯召回网页并输入召回编号 &#34;0476&#34; 来确认收到信件：https://olympusamerica.com/recall。</p>
</div><p>Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch program online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda.</p>
<div class="lb-trans"><p>使用该产品时遇到的不良反应或质量问题可以在线报告给 FDA 的 MedWatch 程序：https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda。</p>
</div><p>For information or to report a problem about the device, please contact the Olympus Technical Assistance Center at 1-800-848-9024, Option 1 or email [email protected].</p>
<div class="lb-trans"><p>如需信息或报告设备问题，请联系奥林巴斯技术支持中心，电话：1-800-848-9024，选项 1，或发送电子邮件至 [email protected]。</p>
</div><p>SOURCE Olympus Corporation</p>
<div class="lb-trans"><p>来源：奥林巴斯公司</p>
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奥林巴斯宣布对一次性结扎装置采取自愿纠正措施