MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL CAMERA HEAD HD 1200 AC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 72203360S

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 04/29/2019

Event Type  malfunction  

Event Description

It was reported that before case, the device was not working, it was shorting out.No patient was involved.

Manufacturer Narrative

An evaluation was performed by smith and nephew and could confirm the customer complaint for the device was not working.A visual inspection was performed and showed the connector end of the camera head to have residue and moisture spots on the inner wall and connecting prongs.This indicated the cap was not sealed tight enough during the cleaning process which created a leak path.No manufacturing related defects were observed.

• Brand Name: SVCE REPL CAMERA HEAD HD 1200 AC
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8644296
• MDR Text Key: 146232852
• Report Number: 3003604053-2019-00063
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885554025897
• UDI-Public: 00885554025897
• Combination Product (y/n): N
• PMA/PMN Number: K014158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203360S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1