MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA CONTROL UNIT HIGH DEF 560P; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72201919
Medical Device Problem Codes	Poor Quality Image (1408); Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a knee surgery, there was smoke coming out of the camera control unit and it was getting hot.The image was flashing.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A review of the customer-supplied video was performed and observed image flashing on a video monitor.A review of the customer-supplied photograph was performed and observed the device serial number to be (b)(6).The complaint of flashing image was confirmed and the root cause was associated with component failure.The complaints of smoke and getting hot could not be confirmed.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: CAMERA CONTROL UNIT HIGH DEF 560P
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11614626
• Report Number: 1643264-2021-01257
• Device Sequence Number: 16925295
• Product Code: GCJ
• UDI-Device Identifier: 03596010643094
• UDI-Public: 03596010643094
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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 Model Number: 72201919
• Device Catalogue Number: 72201919
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1