MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL,CAM CONTROL UNT,HIGH DEF, 560P; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 72200559S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/07/2017

Event Type  malfunction  

Event Description

It was reported that during the hip scope procedure, the camera box was not working properly and displayed no picture.No reported patient injuries.No other complications were noted.

Manufacturer Narrative

Complaint of not working properly could not be reproduced.Product passed functional testing including power cycling during 6 hour burn-in.Control unit was tested at different power input voltage levels ranging from 90 to 220 volts.No power or signal loss occurred during 6 hour testing.All live video outputs (composite, s-video, hd-sdi, etc.) normal.All functions perform as expected.After the evaluation the root cause for the reported issue was determined to be no problem found.A review of the device history record was performed which confirmed no inconsistencies.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SVCE REPL,CAM CONTROL UNT,HIGH DEF, 560P
• 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; austin, TX 78735
• MDR Report Key: 6527353
• MDR Text Key: 74045796
• Report Number: 1643264-2017-00228
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

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: 72200559S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2011
• 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