MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERV REPL HD COUPLER 19.5MM; INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE

Catalog Number 72201635S

Device Problem Misfocusing (1401)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2019

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure, the device would not stay focus secure and lose focus.There was a delay of more than 30 minutes.A backup device was used to complete the procedure with no patient injury reported.

Manufacturer Narrative

An evaluation was performed by smith and nephew and could not confirm the customer complaint for the pieces won't stay together and loose focus.A visual inspection was performed and showed no components of the coupler were loose.The coupler is scratched , dented, and severely faded.Functional inspection was performed and showed when the coupler was attached to the camera system it provided a clear sharp image.This device was shipped to the customer on (b)(6) 2016.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defected were observed.

• Brand Name: SERV REPL HD COUPLER 19.5MM
• Type of Device: INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8873687
• MDR Text Key: 153698328
• Report Number: 3003604053-2019-00090
• Device Sequence Number: 1
• Product Code: FEI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201635S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1