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

Model Number 72202087S

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the lens on the scope was moving.No backup device was available and no delay or 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

H3, h6: the device, which was used in a procedure, was returned for evaluation.The evaluation was performed by the supplier and could confirm the customer complaint for the lens was moving.A visual inspection was performed and showed the scope to have distal tip and fiber damage.A dhr review was performed and showed no non-conformances or deviations associated with the serial number provided.A review of the complaint history records was performed for the reported serial number, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.This failure is confirmed not to originate from manufacturing, packaging, or labeling defects.This damage is caused by contact with another source.No manufacturing related defects were observed.

• 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: 9540055
• MDR Text Key: 179442885
• Report Number: 3003604053-2020-00001
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

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 Model Number: 72202087S
• Device Catalogue Number: ED72202087S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2019
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1