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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
Catalog Number AR-6410
Device Problems Detachment Of Device Component (1104); Device Displays Incorrect Message (2591); Pumping Problem (3016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2018
Event Type  Injury  
Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was received but has not yet been evaluated.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.
 
Event Description
It was reported that the green part of the tubing disengaged and sucked into the channel about 2/3 into the shoulder scope.The nurse reattached it but it would not hold.The surgeon had to change the case to a mini open because the pump would not run correctly unless the nurse held it together during use.The pump displayed a pump failure error message.It was being run at 40 pressure / 100 flow.Patient (b)(6) year old male.
 
Event Description
It was reported that the green part of the tubing disengaged and sucked into the channel about 2/3 into the shoulder scope.The nurse reattached it but it would not hold.The surgeon had to change the case to a mini open because the pump would not run correctly unless the nurse held it together during use.The pump displayed a pump failure error message.It was being run at 40 pressure / 100 flow.Patient 57 year old male.
 
Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was received but has not yet been evaluated.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.
 
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Brand Name
MAIN PUMP TUBING
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
ARTHREX INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key7439298
MDR Text Key105760830
Report Number1220246-2018-00129
Device Sequence Number1
Product Code HRX
UDI-Device Identifier00888867118010
UDI-Public00888867118010
Combination Product (y/n)N
PMA/PMN Number
K083707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/01/2022
Device Catalogue NumberAR-6410
Device Lot Number102489
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age57 YR
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