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

Model Number 72205058

Device Problem No Display/Image (1183)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  malfunction  

Event Description

It was reported that, during a shoulder procedure, the camera head had no picture.There was a backup device available.No delay or patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference case (b)(4).The reported device, used in treatment, was returned to the designated complaint unit for independent evaluation.There was no relationship found between the returned device and the reported incident.Visual inspection of the returned device did not identify any issues.Functional evaluation did not reveal any problems.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of the device history records showed there were no indications to suggest that the lot did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.

• 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: 10849590
• MDR Text Key: 216906304
• Report Number: 1643264-2020-01834
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/11/2021
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1