MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL,VAS,2.7X30DEG,25MM; ARTHROSCOPE

Catalog Number 4130S

Device Problem Bent (1059)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the scope shaft was bent during a procedure which might have resulted in total loss of visibility during the procedure.A backup device was available to complete the procedure without delay.No patient impact was reported.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint for the scope shaft was bent.A visual inspection was performed and showed the scope to have distal tip and fiber damage and a bent outer tube.No manufacturing related defects were observed.No further investigation is required.(b)(4).

• Brand Name: SVCE REPL,VAS,2.7X30DEG,25MM
• Type of Device: ARTHROSCOPE
• 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 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6281597
• MDR Text Key: 66129493
• Report Number: 3003604053-2017-00020
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4130S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2013
• 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