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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE TESTER, ELECTRODE/LEAD, ELECTROENCEPHALOGRAPH

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LAKE REGION MEDICAL ZIPWIRE TESTER, ELECTRODE/LEAD, ELECTROENCEPHALOGRAPH Back to Search Results
Model Number M006630208B0
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
Event Type  malfunction  
Event Description
Zipwire general-purpose non-vascular guidewire was being used to guide into the patient right ureter for a stent exchange and lithotripsy. The zipwire guidewire was found to be severed, confirmed through fluoroscopy. The guidewire was retrieved immediately by the surgeon, and the stent was placed as planned. No harm to the patient was identified, only extending the length of the surgery.
 
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Brand NameZIPWIRE
Type of DeviceTESTER, ELECTRODE/LEAD, ELECTROENCEPHALOGRAPH
Manufacturer (Section D)
LAKE REGION MEDICAL
13024 north main st
trenton GA 30752
MDR Report Key11892878
MDR Text Key252966232
Report Number11892878
Device Sequence Number1
Product Code GYA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM006630208B0
Device Catalogue NumberM006630208B0
Device Lot Number5975145
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2021
Event Location No Information
Date Report to Manufacturer05/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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