Aquamantys 23-317-1Recalls & reported problems
Medtronic Navigation, Inc. · BIPOLAR SEALER 23-317-1 AQM ENDO DBS 8.7 · Class 2
All models of Aquamantys (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169868267), received between Dec 30, 2019 and Nov 4, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Activation Problem1
- Failure to Shut Off1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2021Failure to Shut Off; Failure to Shut Off
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT WHEN THE DOCTOR USED HANDPIECE FOR 5 MINUTES, HE FOUND THAT THE HEMOSTATIC FUNCTION WAS ALWAYS ON. THE DOCTOR TRIED TO RECONNECT THE HANDPIECE BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW HANDPIECE TO COMPLETE THE SURGERY. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12751663 ↗MalfunctionDec 30, 2019Activation Problem; Activation Problem
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS RE PORTED THAT THE TWEEZERS WERE FIRING ALONE WITHOUT MANUAL ACTIVATION DURING A PROCEDURE ON NOVEMBER 20TH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9530037 ↗
Other ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES devices
- Vasoview Hemopro 2 VH-4000Maquet Cardiovascular LLC · Electrosurgical, Cutting & Coagulation & Accessories6 recalls1 death3,232 reports
- LigaSure LF1937Covidien LP · Electrosurgical, cutting & coagulation & accessories3 deaths2,090 reports
- Olympus WB91051WOLYMPUS Winter & Ibe GmbH · Electrosurgical, Cutting & Coagulation & Accessories1 death1,951 reports
- Valleylab FT10 VLFT10GENCovidien LP · Electrosurgical, cutting & coagulation & accessories1 recall5 deaths1,062 reports
- LigaSure LF1837Covidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall967 reports
- LigaSure LF2019Covidien LP · Electrosurgical, cutting & coagulation & accessories948 reports
- VAPR 225028Depuy Mitek, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES895 reports
- LigaSure LF1923Covidien LP · Electrosurgical, cutting & coagulation & accessories855 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page