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

Model Number	72204354S
Medical Device Problem Codes	No Display/Image (1183); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, the light in "lens integrated system wifi version" die.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and a cloudy whitish residue was observed on the edges of the light engine glass rod assembly.The reported malfunction was not observed during functional evaluation.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, or basic signal integrity and timing is not sufficient for continuous operation.A complaint history review concluded this was a repeat issue.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.

• Brand Name: SERVICE REPL LENS INT SYS WIFI VER
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11808642
• Report Number: 1643264-2021-01784
• Device Sequence Number: 3909914
• Product Code: GCJ
• UDI-Device Identifier: 00885556632000
• UDI-Public: 00885556632000
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 72204354S
• Device Catalogue Number: 72204354S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1