MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LENS INTEGRATED SYSTEM WIFI VERSION; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 72204354

Device Problem Unexpected Shutdown (4019)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during an arthroscopic procedure, the light source suddenly went off.After troubleshooting was conducted, the entire system was turned off including the "lens integrated system" and started it all up again.After this, it worked fine and the procedure was successfully completed without significant delay using a back-up device.No patient injuries or 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

Internal complaint reference (b)(4).

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed and found residue on the light engine glass rod assembly.The reported malfunction was not observed during functional evaluation.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event potentially include a mismatched or damp light cable.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.A complaint history review concluded this was a repeat issue.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.

• Brand Name: LENS INTEGRATED SYSTEM WIFI VERSION
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11747398
• MDR Text Key: 248540214
• Report Number: 1643264-2021-01612
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556617878
• UDI-Public: 00885556617878
• Combination Product (y/n): N
• PMA/PMN Number: K153606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204354
• Device Catalogue Number: 72204354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1