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

Model Number	HX-201UR-135
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.
Event or Problem Description
As reported for this event by the customer, during a therapeutic polypectomy procedure while attempting to close the site post polypectomy, the device was closed onto the tissue.However, the device clip was not able to release and be deployed.The drive wire inside the handle was buckling out of the handle.The clip had to be removed by force from the tissue and the device removed.The procedure was completed by using device from miroctech brand.There is no harm or adverse impact to the patient.The patient outcome was normal and as expected.Customer request a replacement of the entire batch of the device owned by the customer with devices from other batches.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.H4: may 2021 (exact date undetermined).A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation results, it is determined that clipping procedure was not completed.Therefore, the clip did not detach from the product.The wire detached from the operating portion while clipping was performed.As a result, the clipping was not completed.A tensile force beyond the resistance strength was applied to the area where the wire was secured in place.This caused the wire to detach from the operating portion.The results of replication testing indicates that the following factor might be the cause of a tensile force beyond the resistance strength 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 instructions for use (ifu) states 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¿ on page 10.Otherwise, perforation, bleeding, or mucous membrane damage may result.Olympus will continue to monitor field performance of 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: 14655846
• Report Number: 8010047-2022-09841
• Device Sequence Number: 4867623
• Product Code: PKL
• UDI-Device Identifier: 04953170353123
• UDI-Public: 04953170353123
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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: 15V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/22/2022
• 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