MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ROTATABLE CLIP FIXING DEVICE

Model Number	HX-201UR-135
Medical Device Problem Codes	Break (1069); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported to olympus that following polyp removal in the rectum, during a colonoscopy procedure, an attempt was made to apply the clip to a mucosal breach, however, the clip did not release from the applicator after closure and remained attached to the control wire, which broke at the handle.The endoscope was removed, leaving the clip with the control wire in place.The scope was reinserted and the clip forcibly removed from the patient.The intended procedure was completed using clips from a different manufacturer.The procedure was completed after a delay, characterized as a few minutes.There was no adverse health effect to the patient that occurred, attributed to the delay.There was no patient injury, associated with the event, reported to olympus.This is report #1 of 3 due to multiple events reported.
Additional Manufacturer Narrative
The suspect device has been returned to olympus, however, an evaluation has not been completed at this time.The investigation is ongoing and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The evaluation of the returned subject device revealed the following: - only wires were sent.- adhesions of foreign materials were not observed on the clip.- the clip arm was slightly closed.- the connecting portion placed between the clip and wire was bent.- the clip could not be released from the wire, and clipping did not complete.- the wire was deformed at the position where the screw was tightened.Replication testing was carried out where it was possible to complete clipping.Resistance of the slider operation during clipping was compared.The result indicates that the resistance of clipping method inferred based on the confirmation of the subject device was greater than the resistance of the clipping method stipulated in the product specification.A review of the device history record found no deviations that could have caused or contributed to the reported problem.A definitive root cause for the reported problem was not established.However, it is likely the reported event occurred because the clipping procedure was not completed.The wire detached from the operating portion while clipping was being performed.The results of replication testing indicates that the following factors may have caused a tensile force beyond the resistance strength that was applied to the area where the wire was secured in place.However, the reported phenomenon could not be replicated therefore, the exact cause could not be determined.- due to buckling of the area where the clip and the wire was connected, resistance strength was increased.- the clip was pressed against an object.This increased a sliding resistance of the slider.The occurrence of the reported incident can be prevented by adhering to the instructions for use (ifu), which state the following: ¿should the slightest irregularity and/or breakage of the parts be suspected, withdraw the instrument from the endoscope immediately according to the steps of: withdrawing the instrument from the endoscope.Otherwise, perforation, bleeding, or mucous membrane damage may result.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Common Device Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• 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: 14210445
• Report Number: 8010047-2022-07047
• Device Sequence Number: 17189369
• Product Code: PKL
• UDI-Device Identifier: 04953170193040
• UDI-Public: 04953170193040
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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-201UR-135
• Device Lot Number: 17V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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
• Patient Sex: Unknown