Dexter Monopolar Hook Dexter L6Recalls & reported problems
Distalmotion SA · Dexter L6 Monopolar Hook · Class 2
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 07640184840622), received between Nov 21, 2025 and Nov 27, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Therapy Delivered to Incorrect Body Area” (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.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event1
- Therapy Delivered to Incorrect Body Area1
Patient problems
- Burn(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2025Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area
DURING A CHOLECYSTECTOMY, A SMALL HOLE WAS OBSERVED IN THE INSULATION OF THE TIP SLEEVE OF THE MONOPOLAR HOOK INSTRUMENT. WHILE APPLYING ENERGY TO DISSECT THE GALLBLADDER, SPARKING WAS NOTED FROM THE HOLE, WHICH RESULTED IN ONE SMALL, LINEAR, CAUTERIZATION MARK TO THE LIVER CAPSULE. THE SAME INSTRUMENT WAS BEING USED FOR APPROXIMATELY 19 MINUTES WITHOUT ISSUES AND WAS EXTRACTED AND RE-INSERTED JUST BEFORE THE EVENT. NO FRICTION WAS REPORTED WHEN PASSING THE MONOPOLAR HOOK THROUGH THE TROCAR. SINCE THIS FINAL SURGICAL TASK REQUIRED LESS THAN 5 MINUTES, THE SURGEON DECIDED TO COMPLETE THE PROCEDURE WITHOUT REPLACING THE INSTRUMENT. THIS RESULTED IN A FEW SIMILAR, SMALL, CAUTERIZATION MARKS ON THE LIVER CAPSULE, CREATED UNDER FULL VISUAL CONTROL AND WITH DELIBERATE, CONTROLLED INSTRUMENT MOVEMENTS. PATIENT HARM WAS LIMITED TO MINOR LINEAR CAUTERIZATION OF THE LIVER CAPSULE, VISIBLE ON VIDEO. NO LACERATION OR HAEMORRHAGE WERE SEEN; NO HEPATIC STRUCTURES WERE INJURED. NO ADDITIONAL INTERVENTIONS WERE PERFORMED OR PLANNED. ENERGY SOURCE USED WAS ETHICON MEGADYNE, SET AT 30.
Patient problems: Burn(s)
MAUDE report 23666057 ↗MalfunctionNov 21, 2025No Apparent Adverse Event; No Apparent Adverse Event
DURING TISSUE COAGULATION IN A REFLUXSTOP¿ DEVICE IMPLANTATION PROCEDURE, IT WAS REPORTED THAT AFTER APPROXIMATELY 40 MINUTES OF USING THE MONOPOLAR HOOK, A SPARK TRAIL INDICATED A DEFECT IN THE TIP SLEEVE. THERE WAS NO HARM TO THE PATIENT. THE INSTRUMENT WAS IMMEDIATELY REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT INCIDENT. THERE WERE NO REPORTS OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23616367 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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