MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COUPLER, HD, 19.5MM; INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE

Catalog Number 72201635

Device Problem Image Resolution Poor (1306)

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

Event Date 07/10/2017

Event Type  malfunction  

Event Description

There has been a defect in the camera console side attachment of camera head.During surgery, the surgeon is not able to get perfect resolution picture.The picture gets blurred occasionally.Due to this issue, the surgeon had to use a non-smith and nephew system which has been working for years.The surgeon is not happy with the smith and nephew system.No injuries or complications were reported as a result.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.Our quality department will continue to monitor for trends.No further investigation is required.

• Brand Name: COUPLER, HD, 19.5MM
• Type of Device: INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 7000 w william cannon drive; austin, TX 78735
• MDR Report Key: 6735455
• MDR Text Key: 80997714
• Report Number: 3003604053-2017-00075
• Device Sequence Number: 1
• Product Code: FEI
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

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: 72201635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 07/24/2017
• Supplement Dates Manufacturer Received: 09/05/2017
• Supplement Dates FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2016
• 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