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

Model Number	HX-610-135
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the clip despite confirming the mucous membrane was firmly grasped, did not release properly.Despite hearing a clicking sound, the clip could not be released from the main body of the clip device.After that, the sheath was moved, and it came off.The event occurred during the therapeutic hemostatic procedure.The procedure was completed using the same set of equipment.There was no report of patient or user harm associated with the event.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The customer¿s allegation of a clip gripping mucosa could not detach was not reproduced.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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.Based on the results of the investigation, the root cause of the reported event is unable to be determined.The event can be detected by following the instructions for use (ifu) which state: ·do not apply excessive bending, pulling or pressure to this product.It may lead to equipment damage or functional deterioration.Do not apply excessive bending, pulling or pressure to this product.Failure to do so may result in equipment damage or reduced 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 smaller than 20cm in diameter.The insertion tube may be damaged.·do not use excessive force to operate each part.It may lead to damage of rotating clip device and clip.Do not operate any parts with excessive force.This may lead to damage to the rotating clip device and the clip.If additional information becomes available, this report will be supplemented accordingly.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: 17997929
• Report Number: 9614641-2023-01581
• Device Sequence Number: 20304435
• Product Code: PKL
• UDI-Device Identifier: 04953170200311
• UDI-Public: 04953170200311
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 1ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• 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: 10/02/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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-110QR
• Patient Sex: Unknown