MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LENS 4K A/C CAMERA HEAD; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 72205058

Device Problems Optical Discoloration (2999); Optical Problem (3001)

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

Event Date 06/24/2020

Event Type  malfunction  

Event Description

It was reported that during knee scope procedure, the camera head had a blinking picture and distorted coloring.No delay and a back up device was used to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was returned to the designated complaint station for independent evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed and no deficiencies were observed.A functional test revealed video flickering when the cable near the camera connector was moved.The complaint was verified and the root cause was associated with component failure.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.

• Brand Name: LENS 4K A/C CAMERA HEAD
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10280722
• MDR Text Key: 199057476
• Report Number: 1643264-2020-00576
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556720790
• UDI-Public: 00885556720790
• Combination Product (y/n): N
• PMA/PMN Number: K191177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72205058
• Device Catalogue Number: 72205058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1