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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 05/31/2022, it was reported by a facility representative via sems that (2) ar-3210-0006 couplers are experiencing an issue with zooming, and auto focusing.The image is not centered on the tower.This occurred on (b)(6) 2022 during a laparoscopic cholecystectomy procedure, the case had to be aborted.No additional information provided.Additional information requested.Additional information provided on 06/07/2022: the patient was sedated with transabdominal preperitoneal block (tapp).There was no skin incision made, an the procedure was aborted.
Additional Manufacturer Narrative
The complaint is confirmed.(1) unpackaged ar-3210-0006 zoom coupler was received for evaluation.Visual inspection revealed an internal lens was detached and remained loose inside the coupler.The device also produced a rattling sound when shook.Functional testing with a camera head revealed the image was not centered on the display, and there were issues with zooming and focusing.Without additional information, a cause cannot be determined.However, a probable cause could be attributed to impact with a hard surface, such as dropping the device on the floor.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14744798
• Report Number: 1220246-2022-05121
• Device Sequence Number: 2214168
• Product Code: FEI
• UDI-Device Identifier: 04056702002268
• UDI-Public: 04056702002268
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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: 10636354
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown