MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE RELOADABLE CLIP APPLICATOR

Model Number	HX-810UR
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the handle of the subject device was deformed during a polypectomy procedure.After the first clip was successfully deployed, the second clip caused a jam and the closing force deformed and bent the handle.The procedure was completed with a new device and two new clips.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The suspect device was not sent to olympus for evaluation.A photograph of the device was provided.The photograph showed an object like a hook protruding from the distal end of the device.However, detailed information could not be obtained from the photograph as the image was unclear.The handle was deformed and bent.A review of the device history record found no deviations that could have caused or contributed to the reported event.The device was shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the user could not pull the slider fully due to poor operability due to buckling of the insertion portion, bending of the hook, or the shape and angulation of the endoscope's insertion portion.The deformation of the handle was likely due to stress above the specified value being generated in the handle.However, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE RELOADABLE CLIP APPLICATOR
• Common Device Name: CLIP APPLICATOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14787526
• Report Number: 8010047-2022-10644
• Device Sequence Number: 5058046
• Product Code: PKL
• UDI-Device Identifier: 04953170421341
• UDI-Public: 04953170421341
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K183590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2022

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-810UR
• Device Lot Number: 0K7149
• Was Device Available for Evaluation?: No
• 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: 05/12/2021
• Initial Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown