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

Catalog Number 72204354S

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2018

Event Type  malfunction  

Event Description

It was reported that the image on screen is all sparkles and only on half the screen.There was no backup device available.No delay or patient injury reported.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event due to the procedure was completed with the same device.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• 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 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8155865
• MDR Text Key: 130210156
• Report Number: 1643264-2018-00980
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556632000
• UDI-Public: 00885556632000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 72204354S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 12/26/2018
• Supplement Dates FDA Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1