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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 Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 09/17/2021
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 09/17/2021, it was reported by an arthrex employee via sems that a set of ar-6410 main pump tubing did not work, causing the console to display "door open". This was discovered during use in a procedure performed on (b)(6) 2021. The case was completed by using gravity-assisted-pumping techniques with no patient effect reported. Update: case is confirmed to be a significant deviation from procedure consistent with aborted procedure - serious injury. Information on pump requested from re and will be entered as second product line when received. Update: contact with rep continued. Rep claimed the issue resulted from a setting mistake when attempting to use the pump and tubing, and the procedure was completed using another device. The part and serial numbers of the pump used could not be identified. Due to lack of complete information, case will be left as reportable, subject to change if more information is obtained.
 
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Brand NameMAIN PUMP TUBING
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key12576908
MDR Text Key274910592
Report Number1220246-2021-03751
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K083707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
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 Number49146491
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2021
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: 10/05/2021 Patient Sequence Number: 1
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