MAUDE Adverse Event Report: ARTHREX, INC. C-MOUNT AR-SCOPE,304X152.5MM LGTH; ARTHROSCOPE

Model Number	C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a knee arthroscopic procedure, the image of the arthroscope, ar-3355-4030 was dull, diffused and blurred.The surgeon attempted to clean the lens but the lens was foggy and still did not give a clear image.No further information provided.The surgeon had to switch to another technique during surgery due to the incident.Surgeon changed to a conventional non-arthroscopic technique.
Additional Manufacturer Narrative
The evaluation confirmed the report of fogging.The root cause, however, is unknown at this time.

• Brand Name: C-MOUNT AR-SCOPE,304X152.5MM LGTH
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8932373
• Report Number: 1220246-2019-01278
• Device Sequence Number: 2048558
• Product Code: HRX
• UDI-Device Identifier: 00888867029842
• UDI-Public: 00888867029842
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
• Device Catalogue Number: AR-3355-4030
• Device Lot Number: 10245767
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 07/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other