MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIDEOARTHORSCOPE HD 4MM X 70 DEG; NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Model Number	72202962S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional 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 distal tip and fiber damage, sidearm lens damage, and a cracked distal 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.Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the scope lens was scratched.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that this unit had a cracked distal lens which makes it a reportable event.

• Brand Name: VIDEOARTHORSCOPE HD 4MM X 70 DEG
• Common Device Name: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11841353
• Report Number: 3003604053-2021-00201
• Device Sequence Number: 3660930
• Product Code: EOB
• UDI-Device Identifier: 00885554024210
• UDI-Public: 00885554024210
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K043395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: 72202962S
• Device Catalogue Number: 72202962S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1