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

Model Number	HX-610-135
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.The report is related to mfr # 9614641 - 2024 - 01601, mfr # 9614641 - 2024 - 01599, and complaint # (b)(6).
Event or Problem Description
It was reported that the clip gripping the mucosa could not be removed during the therapeutic colon polypectomy procedure.It was eventually removed by shaking it and the procedure was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Additional information added to fields d8, d9, h2, h4, h3, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 months since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.As a result, the presumed cause and a definitive root cause could not be determined.The event can be prevented by following the instructions for use: do not apply excessive bending, pulling or pressure to this product.It may led to equipment damage or functional deterioration.Do not round the insertion tube smaller than 20 cm in diameter.The insertion tube may be damaged.Do not use excessive force to operate each part.It may led to damage of rotating clip device and 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: 19967638
• Report Number: 9614641-2024-01612
• Device Sequence Number: 18383064
• Product Code: PKL
• UDI-Device Identifier: 04953170415128
• UDI-Public: 04953170415128
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K240617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX-610-135
• Device Lot Number: 41K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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-11OQR- ROTATABLE CLIP FIXING DEVICE
• Patient Sex: Unknown