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

Catalog Number	72205058S
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the customer could not see through the camera head.No case reported; therefore, there was no patient involvement.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, intended for use in treatment, was returned for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device did not identify any issues.Functional evaluation revealed split screen display and the buttons failed to function.The complaint has been confirmed and the root cause has been associated with an electrical component failure.Factors that could have contributed to the reported event include; a damaged connector.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.

• Brand Name: SERVICE REPLACEMENT 4K A/C CAMERA HEAD
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11573982
• Report Number: 1643264-2021-01159
• Device Sequence Number: 4266462
• Product Code: GCJ
• UDI-Device Identifier: 00885556757017
• UDI-Public: 885556757017
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K191177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: 72205058S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1