Initial reporter name and address:: the full name of the customer establishment is (b)(6).The subject device (used clips) was not returned for evaluation.According to the reporter, the clips that were used were disposed by the customer.(b)(4).According to the reporter, customer does not want to use any other clip from this lot since they are afraid it might occur again.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, possible causes may include: ·the endoscope or the rotatable clip fixing device was pulled while the clip was grasping the body cavity tissues.This applied a tensile force to the joint between the hook and the clip.As a result, the clip was difficult to detach from the hook.·when an attempt was made to release the clip by pushing the slider, the convex area of the hook was facing down.Therefore, the hook did not detach under its own weight and the clip did not detach from the product.A definitive root cause cannot be identified.This issue is covered in the instructions for use: ¿operation of this instrument is based on the assumption that open surgery is possible as an emergency measure if the clip cannot be detached from the instrument or if any other unexpected circumstance takes place.In this case, refer to chapter 14, ¿emergency treatment¿.¿do not withdraw the instrument forcibly or change the angulation of the endoscope when the clip is grasping the tissue and is not released.Doing so may tear tissue inside the body cavity, resulting in patient injury, such as perforation, bleeding, or mucous membrane damage.¿do not angulate the bending section of the endoscope or withdraw the instrument from the endoscope while the clip is grasping the tissue before being released.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.¿do not try to forcibly withdraw the instrument from the endoscope if the clip cannot be detached from the instrument.Forcibly withdrawing the instrument could cause patient injury such as perforation, bleeding, or mucous membrane damage.¿should the slightest irregularity and/or breakage of the parts be suspected, withdraw the instrument from the endoscope immediately according to the steps of ¿withdrawing the instrument from the endoscope¿ on page 10.Otherwise, perforation, bleeding, or mucous membrane damage may result.Olympus will continue to monitor the field performance of this device.
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