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

Model Number	HX-110UR
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed during the device inspection, that the rotatable clip fixing device exhibited operating wire coating of applicator peeled off and fell off.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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, it is likely that the peeling of the coating on the operation wire was caused by factors such as the coating part being rubbed against a hard object during use or reprocessing.However, the exact cause could not be identified.The suggested event is detectable and preventable by handling device in accordance with the following ifu.Keep pinching the grip of the cartridge until the clip is attached completely.Also hold the cartridge straight up, so that the coil sheath does not bend at the grip while attaching the clip.Otherwise, the distal end of the coil sheath may move and a gap in the cartridge can develop.As a result, it could be difficult to attach the clip or open the clip when extended from the coil sheath.In case a gap develops, put the cartridge on the coil sheath once again as described in step 3.Before use, inspect several coil sheaths as instructed and make sure they are not crushed, bent, or deformed.Do not use the clip fixing device if the coil sheath is damaged.Before use, confirm that the hook and/or coil sheath is not corroded, dented, or discolored; do not use the instrument if any of these conditions are observed.A damaged hook and/or coil sheath may fall off the instrument¿s distal end.·when inserting the instrument into the endoscope, hold it close to the biopsy valve and keep it as straight as possible relative to the biopsy valve.Otherwise, the insertion portion could be damaged.Insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.If the insertion portion of the instrument is damaged, the rotation function will be impaired.As the distal end of the coil sheath is thicker than other parts, resistance may be felt when it passes through the section near the biopsy valve.In this case, do not advance it forcibly but gently advance it upright with respect to the biopsy valve.Otherwise, deformation of the coil sheath may result.·do not forcefully squeeze, wipe or scrub the instrument.This could cause damage to the instrument or result in reduced performance.Appearance inspection: 2 gently run your fingertips over the entire length of the insertion portion to check for any slips, bucking, and collapsed broken areas or other damage.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: 20322523
• Report Number: 9614641-2024-01888
• Device Sequence Number: 8005425
• Product Code: PKL
• UDI-Device Identifier: 04953170200229
• UDI-Public: 04953170200229
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: Other
• Device Model Number: HX-110UR
• Device Lot Number: 38K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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