• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARTHREX, INC. CWIII ARTHROSCOPY PUMP ARTHROSCOPE Back to Search Results
Model Number CWIII ARTHROSCOPY PUMP
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2021
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
It was reported that during a knee arthroscopy the pressure of the device could not be regulated. The device pumped fluid with more pressure into the patient than the preset value and the tubing burst. The shoulder joint was pumped up tightly with fluid. In the medical follow-up, the patient did not suffer any consequences. The pump was immediately taken out of service. According to the surgeon no harm for patient, operator or third party occurred. The surgery was finished successfully with a new device with the same part number. It was not necessary to switch the surgical technique or do a second surgery. Update: 20-jul-2021: it was confirmed that no further treatment of the patient was necessary to remove the fluid.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12267116
MDR Text Key264930215
Report Number1220246-2021-03452
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K024291
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
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? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/03/2021 Patient Sequence Number: 1
-
-