MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 660 HD IMS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 72200242

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/25/2016

Event Type  malfunction  

Event Description

It was reported the device locks on photos.

• Brand Name: 660 HD IMS
• 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 dr.; austin, TX 78735
• MDR Report Key: 6972797
• MDR Text Key: 90579082
• Report Number: 1643264-2017-00925
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K060777
• 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: 72200242
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1