MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERV REPL, A'SCOPE, A/C, HD, 30°, 4MM; ARTHROSCOPE

Catalog Number 72202087S

Device Problem Insufficient Information (3190)

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

Event Date 11/05/2019

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the device had a quality issues.No backup device was available.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Updated information.The device, used in a procedure, was returned for evaluation.The evaluation was performed by the supplier and could confirm the customer complaint for the device has quality issues.A visual inspection was performed and showed the scope to have a bent outertube and broken lenses.This damage is caused by contact with another source.Documentation, related to the device history and complaint history, was reviewed and there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SERV REPL, A'SCOPE, A/C, HD, 30°, 4MM
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9380760
• MDR Text Key: 179441885
• Report Number: 3003604053-2019-00138
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010644534
• UDI-Public: 03596010644534
• Combination Product (y/n): N
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

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: 72202087S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1