MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE RELOADABLE CLIP APPLICATOR

Model Number	HX-810UR
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation, and the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that, during an unknown procedure, that the tensioned clip of their single use reloadable clip applicator device remains attached to the applicator after firing and does not come loose.There was no damage to the endoscope.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was not returned to olympus; however, based on the results of a previous reproduction study, the event likely occurred due to the following: 1) clipping when the shape and angle of the scope were strict.2) due to the strict shape, the sliding resistance between the operation wire and the coil sheath increased.3) due to the increased sliding resistance, the force was not transmitted to the tip side, and the slider could not be pulled until the connecting rod broke.4) the clip could not be released because the connecting rod did not break.The event can be detected/prevented by following the instructions for use which state: 1) "do not pull out the rotary clip device until it hits the slider of this product and clipping is not completed.It may lead to perforation, major bleeding, mucous membrane damage, etc." 2) "do not pull the slider of this product until it hits the end, and do not operate the angle of the endoscope before clipping is completed.It may lead to perforation, major bleeding, mucous membrane damage, etc." 3) "if the clip does not come off from the rotating clip device, do not forcibly pull out the sheath.It may lead to perforation, major bleeding, mucous membrane damage, etc." 4) "this product is intended to be used only when surgical operations are possible as an emergency measure.In the unlikely event that the clip does not come off the rotating clip device, see "chapter 4 emergency actions"." 5) "do not press the clip too much against the desired tissue.The intended performance may not be achieved, such as the clip being deformed and not closing completely." 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): 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: 18089433
• Report Number: 9614641-2023-01671
• Device Sequence Number: 5823350
• Product Code: PKL
• UDI-Device Identifier: 04953170390739
• UDI-Public: 04953170390739
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183590
• 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): 12/22/2023

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-810UR
• Device Lot Number: UNKNOWN
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/22/2023
• 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