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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LIGASURE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
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COVIDIEN LP LIGASURE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES Back to Search Results
Model Number LF5644
Device Problems Break (1069); Defective Device (2588); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2023
Event Type  malfunction  
Event Description
No patient involved.When the surgical scrub tech was preparing for a procedure (patient was not in the operating room yet), he opened the package of the device.Upon inspection, he noticed a break or cut on the cable/ cord, exposing the wires underneath.The break did not entirely surround the cable, though.The circulating nurse was informed, and a similar unused/new device replaced the defective device.Manufacturer response for electrosurgical, cutting coagulation accessories, ligasure (per site reporter).Device given to field representative by or supervisor.
 
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Brand Name
LIGASURE
Type of Device
ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
Manufacturer (Section D)
COVIDIEN LP
15 hampshire street
mansfield MA 02048
MDR Report Key17342111
MDR Text Key319203278
Report Number17342111
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10884521521742
UDI-Public(01)10884521521742(17)280422(10)31140219X(20)01
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberLF5644
Device Lot Number31140219X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/01/2023
Event Location Hospital
Date Report to Manufacturer07/18/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/18/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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