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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. CWIII ARTHROSCOPY PUMP ARTHROSCOPE

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ARTHREX, INC. CWIII ARTHROSCOPY PUMP ARTHROSCOPE Back to Search Results
Model Number CWIII ARTHROSCOPY PUMP
Device Problem Pressure Problem (3012)
Patient Problem Swelling/ Edema (4577)
Event Date 10/22/2021
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
On (b)(6) 2021 it was reported by a sales representative via sems that an ar-6410 pump tubing had an issue during an arthroscopic meniscal repair. The pressure of the pump did not decrease during the operation and swelling occurred in the patient's leg. The swelling of the leg healed after the operation, and no abnormality was found on the postoperative x-ray. It has been reported that the membrane of the product was crushed after the operation. After the leg swelling had recovered, the pump was changed and surgery was resumed.
 
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Brand NameCWIII ARTHROSCOPY PUMP
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 Key12814207
MDR Text Key280805475
Report Number1220246-2021-03920
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K024291
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCWIII ARTHROSCOPY PUMP
Device Catalogue NumberAR-6475
Was Device Available for Evaluation? No
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/15/2021 Patient Sequence Number: 1
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