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

Catalog Number 72200242

Device Problems Failure to Capture (1081); Device Operates Differently Than Expected (2913)

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

Event Date 03/22/2017

Event Type  malfunction  

Event Description

It was reported that during a arthroscopy procedure, the device was freezing up causing the physician not to be able to capture the pictures that he is wanting for their cases.There was no back-up device available.No reported patient injuries.No other complications were noted.

Manufacturer Narrative

Complaint of freezing up was confirmed.Also unit fails intermittently with "no op sys found" error message.The hdd failed the hdd scan test with current pending errors and uncorrectable errors.Cause of errors count is a defective hdd.Unit passes functional testing after a known good hdd was installed.This 660 ims is over 7.5 years old and never been serviced.A review of the device history record was performed which confirmed no inconsistencies.After the evaluation the root cause for the reported issue was determined to be expected wear / tear.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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; austin, TX 78735
• MDR Report Key: 6487136
• MDR Text Key: 72787516
• Report Number: 1643264-2017-00205
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

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: 72200242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2009
• 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