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

Model Number	HX-110QR
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the rotatable clip fixing device, tip did not come off properly, and had to forcibly tear it off.The issue occurred during a therapeutic endoscopic hemostasis.There was no report of delay, and the procedure was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.H4: based on the 3-digit lot number provided, the manufacturing date of the device was in the month of march 2022 but a specific date could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction of the clip not coming off the main body was confirmed.Based on the results of the investigation, it is likely the following led to the malfunction: 1.The clip was loaded into the coil sheath with the clip connector pulled.·the tip of the coil sheath was shifted from the center of the cartridge inside the cartridge, so the wings of the clip's holding tube got caught on the tip of the coil sheath when loading the clip.·because the tip of the coil sheath did not completely hit the cartridge, the blade of the holding tube got caught on the tip of the coil sheath.2.As the clip connector was pulled, the wings of the holding tube became difficult to fold, and the sliding resistance between the inner surface of the coil sheath and the wings of the holding tube of the clip increased.3.As the connecting rod was pulled, the wings of the holding tube became difficult to fold, and the sliding resistance between the inner surface of the coil sheath and the wings of the holding tube of the clip increased.However, a definitive root cause could not be determined.The instruction manual contains a warning to the user regarding this event.·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.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: 19147889
• Report Number: 9614641-2024-00945
• Device Sequence Number: 7960539
• 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: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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-110QR
• Device Lot Number: 23K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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
• Patient Sex: Unknown