MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VAS HD AC 4MM X 30 DEG; NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Model Number 72202959

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Foreign zip code: (b)(6).Internal complaint reference: (b)(4).

Event Description

It was reported that the scope had the distal lens cracked.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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 the outer surface dented, distal tip and fiber damage, and a cracked distal negative 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 event.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.

• Brand Name: VAS HD AC 4MM X 30 DEG
• Type of Device: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10869915
• MDR Text Key: 217667979
• Report Number: 3003604053-2020-00151
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 00885554018783
• UDI-Public: 00885554018783
• Combination Product (y/n): N
• PMA/PMN Number: K043395
• 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: 04/17/2021

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: 72202959
• Device Catalogue Number: 72202959
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 04/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1