LigaSure LF1623Recalls & reported problems
Covidien LP · Blunt Tip Open Sealer/Divider · Class 2
All models of LigaSure (32)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521209268), received between Apr 21, 2017 and Oct 8, 2018 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Energy Output To Patient Tissue Incorrect” (6 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Energy Output To Patient Tissue Incorrect6
- Difficult to Open or Close1
- Energy Output Problem1
Patient problems
- No Consequences Or Impact To Patient7
- No Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2018Energy Output Problem; Energy Output Problem
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WAS NOT SEALING.
Patient problems: No Information
MAUDE report 7944424 ↗MalfunctionMay 10, 2018Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect
ACCORDING TO THE REPORTER, DURING GYN PROCEDURE, AFTER MAKING A FEW SEALS, TISSUE WAS NOT SEALED. NEW DEVICE WAS OPENED TO CONTINUE. NO TONES WERE KNOWN TO BE HEARD. THERE WAS NO PATIENT INJURY AND NO BLEEDING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7503387 ↗MalfunctionDec 15, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect
THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD AN ISSUE WITH INADEQUATE SEALING. THE INSTRUMENT WAS IN USE WITH A FORCETRIAD GENERATOR, AND THE ISSUE CONTINUED WHEN TESTED WITH AN LS10 GENERATOR. A NEW DEVICE WAS CONNECTED TO THE GENERATOR AND HAD NO ISSUE WITH SEALING. THERE WERE NO REGRASP ALARMS OR EVIDENCE OF ENERGY DELIVERY, BUT AN END TONE WAS HEARD. NO PATIENT INJURY RESULTED FROM THE ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7123508 ↗MalfunctionDec 15, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect
THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD AN ISSUE WITH INADEQUATE SEALING. THE INSTRUMENT WAS IN USE WITH A FORCETRIAD GENERATOR, AND THE ISSUE CONTINUED WHEN TESTED WITH AN LS10 GENERATOR. A NEW DEVICE WAS CONNECTED TO THE GENERATOR AND HAD NO ISSUE WITH SEALING. THERE WERE NO REGRASP ALARMS OR EVIDENCE OF ENERGY DELIVERY, BUT AN END TONE WAS HEARD. NO PATIENT INJURY RESULTED FROM THE ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7123456 ↗MalfunctionOct 2, 2017Difficult to Open or Close; Difficult to Open or Close
THE CUSTOMER REPORTED THAT DURING PROCEDURE, THE JAWS DID NOT OPEN. FOR THAT REASON, THE JAWS WERE RELEASED FORCIBLY FROM THE TISSUE. A NEW DEVICE WAS USED TO CONTINUE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6907748 ↗MalfunctionAug 25, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect
THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE TONES INDICATED IT WAS WORKING BUT THE JAWS DID NOT SEAL TISSUE. THE DEVICE WAS TESTED WITH ANOTHER GENERATOR AND THE ISSUE CONTINUED. A NEW DEVICE OF THE SAME TYPE WAS USED TO CONTINUE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6822530 ↗MalfunctionAug 25, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect
THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE TONES INDICATED IT WAS WORKING BUT THE JAWS DID NOT CUT OR SEAL TISSUE. THE DEVICE WAS TESTED WITH ANOTHER GENERATOR AND THE ISSUE CONTINUED. A NEW DEVICE OF THE SAME TYPE WAS USED TO CONTINUE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6822514 ↗MalfunctionApr 21, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect
THE CUSTOMER REPORTED THAT DURING A PROCEDURE THE DEVICE WOULD NOT PERFORM AN ADEQUATE SEAL. AN END TONE WAS HEARD, INDICATING A COMPLETED SEAL CYCLE, DURING USE. ANOTHER GENERATOR WAS USED BUT THE ISSUE CONTINUED. A NEW HANDPIECE WAS OPENED AND WORKED FINE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6513558 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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