MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REPLACEMENT LENS 4K CCU WIFI; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	72205059S
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).The reported device, intended for use in treatment, was received for evaluation. there was a relationship found between the returned device and the reported incident. a visual inspection was performed and found residue on the perimeter of the light engine glass rod assembly.No fiber build up on the light engine cooling fins was observed. a functional evaluation revealed the lamp does not light.The front panel and screen icon indicators turn on, indicating the light guide cable was detected. the complaint was confirmed and the root cause was associated with component failure.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, or control board issues. 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 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 concluded this was a repeat issue. no containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that, during set up for surgery, the light source in the "camera control unit (4k, wifi)" did not work.The procedure was successfully completed without significant delay using a back-up device.No patient injuries or other complications were reported.Results of investigation have concluded that this unit's light did not turn on which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: SERVICE REPLACEMENT LENS 4K CCU WIFI
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11770354
• Report Number: 1643264-2021-01658
• Device Sequence Number: 17088288
• Product Code: GCJ
• UDI-Device Identifier: 00885556757031
• UDI-Public: 885556757031
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72205059S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1