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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SHEATH, HF, 2 STOPCOCK FOR 4MM SCOPE; ARTHROSCOPE AND ACCESSORIES

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ARTHREX, INC. SHEATH, HF, 2 STOPCOCK FOR 4MM SCOPE; ARTHROSCOPE AND ACCESSORIES Back to Search Results
Model Number SHEATH, HF, 2 STOPCOCK FOR 4MM SCOPE
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2024
Event Type  malfunction  
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
On 1/18/2024, it was reported by a sales representative via (b)(4) that an ar-3372-4002 sheath stopcock disassociated from the sheath at the welding point.This was discovered during the case with no patient harm.
 
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Brand Name
SHEATH, HF, 2 STOPCOCK FOR 4MM SCOPE
Type of Device
ARTHROSCOPE AND ACCESSORIES
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
emily shafer
8009337001
MDR Report Key18651604
MDR Text Key334676343
Report Number1220246-2024-00790
Device Sequence Number1
Product Code NBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 02/06/2024
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
Device Operator Health Professional
Device Model NumberSHEATH, HF, 2 STOPCOCK FOR 4MM SCOPE
Device Catalogue NumberAR-3372-4002
Device Lot Number1734295
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/18/2024
Initial Date FDA Received02/06/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/02/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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