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

Catalog Number 72201635S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

Awaiting reciept of device.

Event Description

It was reported not holding.No delay was noted.No patient injury or complications were reported.

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.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.No further investigation is required.A review of the device history record was performed which confirmed no inconsistencies.

Manufacturer Narrative

An evaluation was performed by smith & nephew and could not confirm the customer complaint for the device not holding.A visual inspection was performed and showed no damage to the camera coupler.The coupler was attached to the camera system and displayed a clear sharp image.This coupler functioned as intended.No manufacturing related defects were observed.Review of the device history records were performed which confirmed no inconsistencies.There were no indications to suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the device was not holding during the case and no back-up device was available.It is unknown what was used to complete the case.However, no delay, patient injury or other complications were reported.

• Brand Name: SERV REPL, HD COUPLER, 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; austin, TX 78735
• MDR Report Key: 6687554
• MDR Text Key: 79141852
• Report Number: 3003604053-2017-00069
• Device Sequence Number: 1
• Product Code: FEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201635S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1