MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. CLIP

Model Number	HX-610-135
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifier: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, when the clip was used in combination with the rotatable clip fixing device during a polypectomy, the clip did not come off the sheath and was pulled while grasping the mucous membrane, resulting in heavy bleeding.The physician manually sutured the rectum, and the procedure was completed.There were no reports of further patient harm.
Additional Manufacturer Narrative
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.The device manufacturing date is september 2023.Based on the results of the investigation, the root cause of the event was unable to be identified.The event was unable to be confirmed.As the event was unable to be reproduced by olympus.The event can be detected/prevented.By following the instructions for use which state: do not apply excessive bending, pulling or pressure to this product.It may lead to equipment damage or functional deterioration.Do not bend, pull or compress the product excessively, as this may result in damage to the device or a decrease in its functionality.Do not round the insertion tube smaller than 20 cm in diameter.The insertion tube may be damaged.Do not roll the insertion tube into a diameter smaller than 20 cm, as this may cause damage to the insertion tube.Do not use excessive force to operate each part.It may lead to damage of rotating clip device and clip.Do not use excessive force when operating any part, as this may result in damage to the rotating clip device and the clip.Olympus will continue to monitor field performance for this device.

• Brand Name: CLIP
• Common Device Name: CLIP
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19088985
• Report Number: 9614641-2024-00898
• Device Sequence Number: 20608518
• Product Code: PKL
• UDI-Device Identifier: 04953170415128
• UDI-Public: 04953170415128
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX-610-135
• Device Lot Number: 39K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HX-110UR (ROTATABLE CLIP FIXING DEVICE)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown