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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. MAIN PUMP TUBING ARTHROSCOPE

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ARTHREX, INC. MAIN PUMP TUBING ARTHROSCOPE Back to Search Results
Model Number MAIN PUMP TUBING
Device Problems Inability to Irrigate (1337); Structural Problem (2506); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2019
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. Device disposition is unknown. The root cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It wa reported via fda medwatch letter (mw5087791) that the following incident has been reported: the sensor in fluid chamber of the arthroscopy pump tubing noted to be "flat" in appearance. Did not regulate the inflow of irrigation fluid to left knee, causing fluid subligation to subcutaneous tissue left knee to groin. Procedure: arthroscopy left knee. The medwatch letter did not contain any reporter or facility name or contact information. Therefore no follow up can be performed at this time.
 
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Brand NameMAIN PUMP TUBING
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 Key8861639
MDR Text Key153364972
Report Number1220246-2019-01229
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 08/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMAIN PUMP TUBING
Device Catalogue NumberAR-6410
Device Lot Number32454024
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/05/2019 Patient Sequence Number: 1
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