MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REPL CAMERA HEAD LENS INT SYS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72203967S
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the camera head lens was not working, the image was poor and it could not take pictures.The incident occurred before the procedure.There was no delay and a backup device was available to complete the procedure with no complications reported.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was returned to the designated complaint unit 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 that the left button failed to function.The zoom and brightness functions could not be adjusted from the device due to the button failure.The complaint has been confirmed and the root cause has been associated with a mechanical component failure.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event include failed button switches.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 REPL CAMERA HEAD LENS INT SYS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11920686
• Report Number: 1643264-2021-02043
• Device Sequence Number: 11860883
• Product Code: GCJ
• UDI-Device Identifier: 00885556631980
• UDI-Public: 00885556631980
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K153606
• 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): 07/02/2021

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: 72203967S
• Device Catalogue Number: 72203967S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1