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

Model Number	72205059
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during use in a shoulder surgery, the image on the "lens 4k camera control unit" disappeared.The fan was working, no led lights on.I turned it off, and started it again.Smith and nephew logo appeared on the screen (only the smith and nephew logo on black screen), noting else happened.I restarted it again, checked the camera connection, it worked and then after about 10 minutes the same thing happened again.After that the surgeons decided to cancel the surgery.
Additional 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 no deficiencies were observed.The reported malfunction was not observed during functional evaluation.The device was powered for 1-hour and no reset of power, image display or wi-fi was observed.The device was also tested at 230vac, and the reported malfunction was not observed.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.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.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 resulting in a light engine thermostat failure, or other component issue.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.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.No containment or corrective actions are recommended at this time.

• Brand Name: LENS 4K CCU WIFI VERSION
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 12242129
• Report Number: 1643264-2021-02231
• Device Sequence Number: 19824004
• Product Code: GCJ
• UDI-Device Identifier: 00885556720844
• UDI-Public: 00885556720844
• Combination Product (Y/N): N
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72205059
• Device Catalogue Number: 72205059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1