MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERV REPL ASCOPE A/C HD 30 DEG 4MM ARTHROSCOPE

Model Number 72202087S

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The reported device, intended for use in treatment, was received for evaluation. There was a relationship found between the returned device and the reported incident.  a visual inspection found a cracked distal lens and negative lens damage. A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.  a complaint history review concluded this was a repeat issue. The complaint was confirmed. Factors that could have contributed to the reported event include an impact event inconsistent with normal use. Internal complaint reference: case-(b)(4).

Event Description

It was reported that the arthroscope was found to have damage to the negative lens. No case reported. Results of investigation have concluded that this unit had a cracked distal lens which makes it a reportable event.

• Brand Name: SERV REPL ASCOPE A/C HD 30 DEG 4MM
• 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11947694
• MDR Text Key: 254586609
• Report Number: 3003604053-2021-00217
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 72202087S
• Device Catalogue Number: 72202087S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/03/2021
• 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: Unkown