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U.S. Department of Health and Human Services

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

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ARTHREX, INC. C-LINE CARPAL TUNNEL SCOPE,30,2.9X158MM ARTHROSCOPE Back to Search Results
Model Number C-LINE CARPAL TUNNEL SCOPE,30°,2.9X158MM
Device Problem Material Opacification (1426)
Patient Problem Insufficient Information (4580)
Event Date 08/11/2021
Event Type  Injury  
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. If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
It was reported on (b)(6) 2021 during a procedure, the arthroscope, ar-3350-2930, was found to be cloudy. A backup scope was not available and the surgeon converted to an open procedure to complete the case. No further information provided.
 
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Brand NameC-LINE CARPAL TUNNEL SCOPE,30,2.9X158MM
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key12434700
MDR Text Key270164343
Report Number1220246-2021-03608
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberC-LINE CARPAL TUNNEL SCOPE,30°,2.9X158MM
Device Catalogue NumberAR-3350-2930
Device Lot Number10224499
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/07/2021 Patient Sequence Number: 1
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