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

Model Number 72204354S

Device Problems No Display/Image (1183); Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2020

Event Type  malfunction  

Event Description

It was reported that the lens had an electrical issue and there was no video, it had to be restarted.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3,h6: 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 of no video.There was a relationship found between the returned device and the reported incident of an electrical issue.A visual inspection was performed and found residue on the light engine glass rod assembly.A functional evaluation revealed a purple tint to the displayed image.The device would not white balance.The device did white balance once the head was removed and reinserted.No other electrical issues were observed.The complaint of no video 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 occurrence of the reported event.A complaint history review concluded this was a repeat issue.The complaint of electrical issue was verified and the root cause was associated with component failure.A complaint history review concluded a complaint of electrical issue was an isolated event.

• Brand Name: SERVICE REPL LENS INT SYS WIFI VER
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10477286
• MDR Text Key: 205128145
• Report Number: 1643264-2020-01022
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556632000
• UDI-Public: 00885556632000
• Combination Product (y/n): N
• PMA/PMN Number: K153606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204354S
• Device Catalogue Number: 72204354S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1