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

Model Number	72202961
Medical Device Problem Code	Optical Obstruction (3002)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon checking the camera system before an arthroscopy procedure, it was noticed that the picture was not clear, it was black when looking through the videoarthroscope which appears damaged.The procedure was completed using a competitor device with a delay shorter than 30 minutes.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: prior to each use, inspect the device to ensure it is functioning properly and not damaged.Do not use a damaged device.To avoid fogging during surgery, the rear portion of the scope must be entirely free of moisture before attachment to either the camera head or camera coupler.Caution must be taken to dry-out mating portions of both the scope and camera head; otherwise trapped moisture may condense on glass surfaces, blurring the image.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: VIDEOARTHROSCOPE HD 4MM X 30 DEG
• Common Device Name: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10865845
• Report Number: 3003604053-2020-00150
• Device Sequence Number: 2799490
• Product Code: EOB
• UDI-Device Identifier: 00885554024159
• UDI-Public: 00885554024159
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72202961
• Device Catalogue Number: 72202961
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention