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

Model Number	HX-110QR
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, during hemostasis after the removal of a colonic polyp, when using the rotatable clip fixing device for the first time, the clip could not be detached, no matter how many times it was moved from the main body.The procedure was prolonged by ten minutes.The patient did not require additional anesthesia.The procedure was completed using a similar rotatable clip fixing device.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The customer's allegation was not confirmed as the device was tested with our own clips and the clip could be loaded without any problems.There was no bucling at the insertion site.Lastly, there was no problems with protruding or retracting the hook and there were no bends or other abnormalities in the hook.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It is unknown at what section of the large intestine the reported issue occurred.Although the clip would not detach, it was removed by "moving the main body of the clipping device.".
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 reported event could not be confirmed.Therefore, the root cause could not be determined.The event can be detected/prevented 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 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 lead to damage of rotating clip device and clip.¿ this supplemental report includes additional information added to b5.Also, a correction has been made to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: ROTATABLE CLIP FIXING DEVICE
• Common Device Name: ROTATABLE CLIP FIXING DEVICE
• 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: 18071033
• Report Number: 9614641-2023-01660
• Device Sequence Number: 7665181
• Product Code: PKL
• UDI-Device Identifier: 04953170200205
• UDI-Public: 04953170200205
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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-110QR
• Device Lot Number: 33K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HX-610-135 - CLIP.
• Patient Sex: Unknown