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

Catalog Number 72201635S

Device Problem Break (1069)

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

Event Date 10/17/2016

Event Type  malfunction  

Event Description

It was reported that the device had broken parts.No patient injury or complications were reported.

Manufacturer Narrative

Review of the device history records were performed which confirmed no inconsistencies.

Manufacturer Narrative

An evaluation was performed by the smith & nephew and could confirm the customer complaint for the devise having a broken part.A visual inspection was preformed and showed the coupler has been used in field.This device was shipped to the customer in 2011.The eyepiece is cracked exposing the o-ring.This is caused by hard contact to the eyepiece.No manufacturing related defects were observed.

• 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: james gonzales ; 7000 w. william cannon dr.; austin, TX 78735 ; 5123585706
• MDR Report Key: 6084162
• MDR Text Key: 59599940
• Report Number: 3003604053-2016-00107
• Device Sequence Number: 1
• Product Code: FEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• 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: BBB2125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1