MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL,A'SCOPE,A'CLAV; ACCESSORIES,ARTHROSCOPIC

Catalog Number 3894S

Device Problem Unintended Collision (1429)

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

Event Date 02/01/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Twelve of fourteen scopes were returned for evaluation.Visual inspection confirmed the reported complaint.The distal tips are damaged and melted.This damage is caused by contact with another source like a shave or rf probe.No manufacturing related defects were observed.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

The hospital has reported issues with arthroscopes.There were informed that the issues they are having are the result of the scopes being struck with a shaver, or being subject to electrical contact with an rf probe.No fragments of the device or debris were reported to have been left in the patient(s).No patient injury or other complications were reported.Report 9 of 14.

• Brand Name: SVCE REPL,A'SCOPE,A'CLAV
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5979015
• MDR Text Key: 55690497
• Report Number: 3003604053-2016-00093
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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
• Report Date: 02/28/2014

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: 3894S
• Device Lot Number: QH527955
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2014
• Initial Date FDA Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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