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	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).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 noted frayed and stretched cord due to autoclave damage.Functional evaluation revealed that there was loss of image when the cable is flexed near the stain relief.The complaint was confirmed.Certain cleaning or disinfecting chemicals coming into contact with the cable could have contributed to the deterioration of observed.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 the set-up of an unknown procedure, the service repl camera head lens int sys was not working.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.Results of investigation have concluded that this unit had loss of image when the cable is flexed near the stain relief 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 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: 11729401
• Report Number: 1643264-2021-01554
• Device Sequence Number: 11748784
• Product Code: GCJ
• UDI-Device Identifier: 00885556631980
• UDI-Public: 00885556631980
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• 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 Model Number: 72203967S
• Device Catalogue Number: 72203967S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial 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