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

Model Number COUPLER, ZOOM, HD, C-MOUNT

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 294877994
• Report Number: 1220246-2022-05121
• Device Sequence Number: 1
• Product Code: FEI
• UDI-Device Identifier: 04056702002268
• UDI-Public: 04056702002268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other