MAUDE Adverse Event Report: ARTHREX, INC. C-LINE CARPAL TUNNEL SCOPE,30°,2.9X158MM; ARTHROSCOPE

Model Number	C-LINE CARPAL TUNNEL SCOPE,30°,2.9X158MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
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 at the start of a procedure, the surgeon could not see easily through the arthroscope, ar-3350-2930.The scope was foggy, and the staff in the or could not fix it.After struggling for a few minutes with the scope, the surgeon decided to do the specific procedure open, as the scope was unusable.No further information provided.
Additional Manufacturer Narrative
The evaluation confirmed the reported event.The cause was attributed to damage to the device and the presence of contamination/debris on the interior of the tip.

• Brand Name: C-LINE CARPAL TUNNEL SCOPE,30°,2.9X158MM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8735880
• Report Number: 1220246-2019-01159
• Device Sequence Number: 11406117
• Product Code: HRX
• UDI-Device Identifier: 00888867029583
• UDI-Public: 00888867029583
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 03/27/2020

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-LINE CARPAL TUNNEL SCOPE,30°,2.9X158MM
• Device Catalogue Number: AR-3350-2930
• Device Lot Number: 10272246
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 03/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other