MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL ASCOPE 1.9MM X 30; ARTHROSCOPE

Model Number 4184S

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).The sample is under evaluation by the manufacturing site.

Event Description

It was reported that the part of the image in the scope was blurry.No case involved.Preliminary results of investigation have concluded that this device had compact lens cracked which makes it a reportable event.

Manufacturer Narrative

Internal complaint reference (b)(4).H10, h3, h6: 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 bent needle, distal tip and fiber damage, and a scratched and cracked compact lens.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.No containment or corrective actions are recommended at this time.

• Brand Name: SVCE REPL ASCOPE 1.9MM X 30
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11809629
• MDR Text Key: 262228506
• Report Number: 3003604053-2021-00184
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010125569
• UDI-Public: 03596010125569
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4184S
• Device Catalogue Number: 4184S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1