MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC, CAMERA HEAD, NON-AC, HD560H; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 72200561S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the camera shorts out when plugged in.

• Brand Name: SVC, CAMERA HEAD, NON-AC, HD560H
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6974805
• MDR Text Key: 90797428
• Report Number: 1643264-2017-01007
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K070266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200561S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1