MAUDE Adverse Event Report: ARTHREX, INC. COUPLER, ZOOM, HD, C-MOUNT; INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE

Model Number	COUPLER, ZOOM, HD, C-MOUNT
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that upon inspection of the c-mount zoom coupler, ar-3210-0006, it had clear visible damage and the coupler did not screw into the scope properly.The broken coupler was tagged for isolation and, in this instance, it was not used.Unfortunately it was put back into service and the next surgeon operated using the damaged coupler.During a cystoscopy procedure, the c-mount zoom coupler, ar-3210-0006, was used and pierced the patient's bladder wall leading to an overnight stay in the hospital to monitor patients condition.No further details provided, additional information has been requested.Additional information provided 5/1/2019: the zoom optical c-mount coupler was not able to screw in properly to the c-mount camera.During the operation the coupler disengaged from the camera and the scope inadvertently pierced the patients bladder wall.The scope used was not an arthrex scope.At this stage the primary objective of the cystoscopy was already completed and the surgeon was happy to end the case.The patient was admitted overnight post surgery for observation purposes.No subsequent issues were reported and they where allowed to go home the following morning.
Additional Manufacturer Narrative
The evaluation confirmed the damage to the device.Consequently, the device was not able to adequately secure the test scope.The cause was attributed to mishandling/misuse.

• Brand Name: COUPLER, ZOOM, HD, C-MOUNT
• Common Device Name: INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8611494
• Report Number: 1220246-2019-01097
• Device Sequence Number: 11393723
• Product Code: FEI
• UDI-Device Identifier: 04056702002268
• UDI-Public: 04056702002268
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: COUPLER, ZOOM, HD, C-MOUNT
• Device Catalogue Number: AR-3210-0006
• Device Lot Number: 10262343
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other