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

Model Number	HX-201UR-135
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported to olympus during a therapeutic colonoscopy, the single use rotatable clip fixing device would not deploy properly from the insertion wire when trigger was pulled.The clip did not attach to the tissue at the treatment site.A second clip fell off into the scope channel.The procedure was completed using a replacement device.There was no report of patient harm associated with this event.Related patient identifier: (b)(6).
Additional Manufacturer Narrative
The subject device will not be returned to olympus for evaluation.The clips were disposed of at the end of procedure.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h4, h6 and h10.H4: based on the 3 digit lot number provided, the manufacturing date of the device was in the month of july 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.The device was discarded after the procedure.Although a definitive root cause could not be identified, a likely mechanism causing the reported event includes: due to severe angle of the endoscope or the shape of the insertion portion, sliding resistance between the operating wire and the coil sheath increased.The slider could not be fully pulled, and clipping could not be completed.The clip was caught in the hook of the slightly bent connecting board, and the coil sheath could not be detached.The following is included in the instructions for use: ¿do not coil the insertion portion with a diameter of less than 20 cm.This could damage the insertion portion.Do not force the clip against body cavity tissue.The clip may be deformed and does not close properly.This could result in reduced performance.Do not try to forcibly remove the clip if it becomes caught on the distal end of the coil sheath.Forcible removal of the clip could cause patient injury such as punctures, hemorrhages or mucous membrane damage.¿ 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): 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: 17297551
• Report Number: 9614641-2023-00966
• Device Sequence Number: 17901520
• Product Code: PKL
• UDI-Device Identifier: 04953170353123
• UDI-Public: 04953170353123
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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: 27V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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