n.a. 26775UERecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04048551072394), received between Jun 13, 2022 and Sep 11, 2026 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Overheating of Device

  Patient problems: Burn(s)

  MAUDE report 50743124 ↗
• InjurySep 11, 2026Overheating of Device

  Patient problems: Burn(s)

  MAUDE report 50743114 ↗
• InjuryJun 25, 2026Temperature Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC ABDOMINOPERINEAL RESECTION FOR CANCER. DURING THE DISSECTION, A MONOPOLAR SCALPEL WITH A SPATULA-SHAPED TIP WAS USED; DUE TO A DEFECT IN THE SHEATH COVERING THE SHAFT, THIS CAUSED SEVERAL THERMAL INJURIES TO THE SEROSA OF THE SMALL INTESTINE AND THE LARGE INTESTINE. THESE LESIONS WERE SUPERFICIAL HEAT INJURIES AND DID NOT RESULT IN PERFORATION. THEY WERE TREATED BY APPLYING REINFORCEMENT SUTURES. SINCE THE PATIENT GOT INJURED, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: Burn(s)

  MAUDE report 25623538 ↗
• InjuryApr 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGERY, A MONOPOLAR SPATULA WAS CONNECTED TO A VALLEYLAB FT10 AND INITIALLY USED WITH A POWER PLATFORM SET AT 20 W FOR PURE CUT AND COAGULATION. AS THE ENERGY OUTPUT WAS CONSIDERED INSUFFICIENT TO ACHIEVE THE DESIRED TISSUE EFFECT, THE SURGEON REQUESTED AN INCREASE IN POWER TO 30 W. UPON ACTIVATING THE ENERGY USING THE MONOPOLAR PEDAL, IGNITION (SPARK/FIRE) OCCURRED AT THE MONOPOLAR INSTRUMENT. THE INSTRUMENT WAS IMMEDIATELY REMOVED FROM THE PATIENT'S CAVITY AND ITS USE WAS DISCONTINUED. A LIGASURE MARYLAND DEVICE WAS THEN INTRODUCED AS A SUBSTITUTE. HOWEVER, UPON ACTIVATING THE ENERGY WITH THE LIGASURE DEVICE INSIDE THE PATIENT'S CAVITY, AN ENERGY OVERLOAD OCCURRED IN THE DEVICE, RESULTING IN THERMAL DAMAGE (BURNS) TO THE SURGICAL CANNULA. FOLLOWING THE EVENT, AN EXPLORATORY INSPECTION OF THE PATIENT'S ABDOMINAL CAVITY WAS PERFORMED USING THE LAPAROSCOPE. THE INSPECTION REVEALED: THERMAL INJURIES TO THE PATIENT'S ABDOMINAL WALL, ATTRIBUTED TO THE ENERGY OVERLOAD CAUSED BY THE LIGASURE DEVICE. PRESENCE OF MELTED POLYMERIC DEBRIS WITHIN THE CAVITY, ORIGINATING FROM THE COMPROMISED CANNULA STRUCTURE. CORRECTIVE ACTIONS / CLINICAL OUTCOME: D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988520 ↗
• InjuryApr 24, 2026Fire; Sparking; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGERY, A MONOPOLAR SPATULA WAS CONNECTED TO A VALLEYLAB FT10 AND INITIALLY USED WITH A POWER PLATFORM SET AT 20 W FOR PURE CUT AND COAGULATION. AS THE ENERGY OUTPUT WAS CONSIDERED INSUFFICIENT TO ACHIEVE THE DESIRED TISSUE EFFECT, THE SURGEON REQUESTED AN INCREASE IN POWER TO 30 W. UPON ACTIVATING THE ENERGY USING THE MONOPOLAR PEDAL, IGNITION (SPARK/FIRE) OCCURRED AT THE MONOPOLAR INSTRUMENT. THE INSTRUMENT WAS IMMEDIATELY REMOVED FROM THE PATIENT'S CAVITY AND ITS USE WAS DISCONTINUED. A LIGASURE MARYLAND DEVICE WAS THEN INTRODUCED AS A SUBSTITUTE. HOWEVER, UPON ACTIVATING THE ENERGY WITH THE LIGASURE DEVICE INSIDE THE PATIENT'S CAVITY, AN ENERGY OVERLOAD OCCURRED IN THE DEVICE, RESULTING IN THERMAL DAMAGE (BURNS) TO THE SURGICAL CANNULA. FOLLOWING THE EVENT, AN EXPLORATORY INSPECTION OF THE PATIENT'S ABDOMINAL CAVITY WAS PERFORMED USING THE LAPAROSCOPE. THE INSPECTION REVEALED: THERMAL INJURIES TO THE PATIENT'S ABDOMINAL WALL, ATTRIBUTED TO THE ENERGY OVERLOAD CAUSED BY THE LIGASURE DEVICE. PRESENCE OF MELTED POLYMERIC DEBRIS WITHIN THE CAVITY, ORIGINATING FROM THE COMPROMISED CANNULA STRUCTURE. CORRECTIVE ACTIONS / CLINICAL OUTCOME: D

  Patient problems: Burn(s); Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988336 ↗
• MalfunctionFeb 5, 2026Overheating of Device

  IT WAS INITIALLY REPORTED THAT THE TIP OF THE ELECTRODE BURNED DURING THE SURGERY. HOWEVER, IT WAS LATER CLARIFIED THAT THE INSTRUMENT DID NOT HAVE A BURNT TIP, INSTEAD, IT WAS THE INSULATION OF THE ELECTRODE TIP THAT WAS DEFECTIVE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269793 ↗
• InjuryAug 25, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A INCOMPLETE SHIELDING WERE DETERMINED BURNS TO THE PATIENT'S UTERUS AND PERITONEUM PARIETAL, FORTUNATELY WITHOUT THE NEED FOR REPAIR SURGERY. A SMALL SOLUTION OF CONTINUOUS OF THE MONOPOLAR SPATULA STEM COATING WAS THEN DETECTED, WHICH RESULTED IN THE AFOREMENTIONED BURNS OUTSIDE THE SURGICAL FIELD.

  Patient problems: Burn(s)

  MAUDE report 22890929 ↗
• InjuryAug 25, 2025Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT A INCOMPLETE SHIELDING WERE DETERMINED BURNS TO THE PATIENT'S UTERUS AND PERITONEUM PARIETAL, FORTUNATELY WITHOUT THE NEED FOR REPAIR SURGERY. A SMALL SOLUTION OF CONTINUOUS OF THE MONOPOLAR SPATULA STEM COATING WAS THEN DETECTED, WHICH RESULTED IN THE AFOREMENTIONED BURNS OUTSIDE THE SURGICAL FIELD.

  Patient problems: Burn(s)

  MAUDE report 22890144 ↗
• InjuryJun 12, 2025Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF THE CAUTERISATION INSTRUMENT USED DURING LAPAROSCOPIC SURGERY (ELECTRIFIED SPATULA FOR ELECTRODISSECTION) DURING AN ANTERIOR RECTAL RESECTION. THE CAUSE OF THE MALFUNCTION WAS IDENTIFIED AS DAMAGE TO THE INSTRUMENT'S SHIELDING, WHICH CAUSED VISCERAL DAMAGE OUTSIDE THE SURGICAL FIELD. THIS DAMAGE WAS PROMPTLY REPAIRED BY SUTURING. A SOLUTION OF CONTINUOUS ON THE COATING OF THE SHAFT WAS ALSO FOUND, WHICH CAUSED A BURN ON THEINTESTINE.

  Patient problems: Bowel Burn

  MAUDE report 22199914 ↗
• InjuryJun 12, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF THE CAUTERISATION INSTRUMENT USED DURING LAPAROSCOPIC SURGERY (ELECTRIFIED SPATULA FOR ELECTRODISSECTION) DURING AN ANTERIOR RECTAL RESECTION. THE CAUSE OF THE MALFUNCTION WAS IDENTIFIED AS DAMAGE TO THE INSTRUMENT'S SHIELDING, WHICH CAUSED VISCERAL DAMAGE OUTSIDE THE SURGICAL FIELD. THIS DAMAGE WAS PROMPTLY REPAIRED BY SUTURING. A SOLUTION OF CONTINUOUS ON THE COATING OF THE SHAFT WAS ALSO FOUND, WHICH CAUSED A BURN ON THE INTESTINE.

  Patient problems: Bowel Burn

  MAUDE report 22199832 ↗
• MalfunctionMay 9, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED "DURING THE SETUP OF THE OPERATING CART FOR LAPAROSCOPIC PROCEDURE, THE INSTRUMENT NURSE FOUND AN ABNORMALITY ON THE INSTRUMENT IN USE: THE INSULATING COVER OF THE COAGULATING AND DISSECTING ELECTRODE SHOWED OBVIOUS SIGNS OF DAMAGE. IN PARTICULAR, THE INSULATION WAS VISIBLY DETERIORATED, NO LONGER SMOOTH NOR UNIFORM, AS IF IT HAD PARTIALLY MELTED AND DETACHED, STARTING FROM THE UPPER END AND DESCENDING TOWARD THE LOWER PART OF THE ELECTRODE., THE DEVICE HAS BEEN REMOVED FROM THE OPERATING ROOM. THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998247 ↗
• InjuryApr 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING LAPAROSCOPIC SURGERY, A MALFUNCTION OF THE CAUTERY DEVICE HAS BEEN REPORTED, DUE TO AN INCOMPLETED SHIELDING, WHICH CAUSED DAMAGES TO THE RECTUM, OUT FROM THE OPERATIVE FIELD. IN PARTICULAR, MALFUNCTIONING IS RELATED TO A SMALL BREACH IN THE PROTECTIVE COATING OF THE DEVICE, LOCATED AT 10 CM UPSTREAM OF THE DISTAL END. THAT CAUSED A LATERAL CURRENT DISCHARGE DURING ELECTRICAL DISSECTION. [THIS] RESULTED IN DAMAGE AT RECTUM LEVEL. THE PATIENT HAS BEEN DISCHARGED WITHOUT ANY PERMANENT DAMAGE, AS A RESULT OF THE EVENT. THE BURN, CAUSED BY THE DEVICE, AFFECTED AN INTESTINE SECTION, WHICH WAS REMOVED DURING SURGERY. THE REMOVAL OF THE AFFECTED INTESTINAL PART WAS NECESSARY FOR THE SUCCESSFUL OUTCOME OF THE SURGERY AND WAS NOT RELATED DIRECTLY TO THE BURN.

  Patient problems: Bowel Burn

  MAUDE report 21766673 ↗
• InjuryApr 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING LAPAROSCOPIC SURGERY, A MALFUNCTION OF THE CAUTERY DEVICE HAS BEEN REPORTED, DUE TO AN INCOMPLETED SHIELDING, WHICH CAUSED DAMAGES TO THE RECTUM, OUT FROM THE OPERATIVE FIELD. IN PARTICULAR, MALFUNCTIONING IS RELATED TO A SMALL BREACH IN THE PROTECTIVE COATING OF THE DEVICE, LOCATED AT 10 CM UPSTREAM OF THE DISTAL END. THAT CAUSED A LATERAL CURRENT DISCHARGE DURING ELECTRICAL DISSECTION. [THIS] RESULTED IN DAMAGE AT RECTUM LEVEL. THE PATIENT HAS BEEN DISCHARGED WITHOUT ANY PERMANENT DAMAGE, AS A RESULT OF THE EVENT. THE BURN, CAUSED BY THE DEVICE, AFFECTED AN INTESTINE SECTION, WHICH WAS REMOVED DURING SURGERY. THE REMOVAL OF THE AFFECTED INTESTINAL PART WAS NECESSARY FOR THE SUCCESSFUL OUTCOME OF THE SURGERY AND WAS NOT RELATED DIRECTLY TO THE BURN.

  Patient problems: Bowel Burn

  MAUDE report 21766672 ↗
• InjuryFeb 5, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHILE PERFORMING HEMESTASIS OF THE LIVER, THE DEVICE HAD ISSUE IN PROTECTIVE SHEATH WHICH HAS CAUSE TWO BURN AT THE PILOR/DUODENA BULB LEVEL.

  Patient problems: Burn(s)

  MAUDE report 18642461 ↗
• InjuryOct 25, 2022Melted; Melted

  THE EVENT OCCURRED IN SINGAPORE: IT HAS BEEN REPORTED THAT THE OVERLAP SPADE AND THE INSULATION OF THE COAGULATION AND DISSECTION ELECTRODE MELTED DURING ACTIVATION AND CAUSED A BURN IN THE PATIENT. INTERNAL REFERENCE NUMBER: (B)(4).

  Patient problems: Gastroesophageal Burn

  MAUDE report 15668000 ↗
• InjuryOct 25, 2022Melted; Melted

  THE EVENT OCCURRED IN SINGAPORE: IT HAS BEEN REPORTED THAT THE OVERLAP SPADE AND THE INSULATION OF THE COAGULATION AND DISSECTION ELECTRODE MELTED DURING ACTIVATION AND CAUSED A BURN IN THE PATIENT. INTERNAL REFERENCE NUMBER: (B)(4).

  Patient problems: Gastroesophageal Burn

  MAUDE report 15667737 ↗
• InjuryJun 13, 2022Material Puncture/Hole; Temperature Problem; Material Puncture/Hole; Temperature Problem

  AS PER MANUFACTURER INCIDENT REPORT #(B)(4) RECEIVED FROM THE FACTORY IN GERMANY: THE REPORTED EVENT HAPPENED IN SINGAPORE. ACCORDING TO THE INFORMATION AVAILABLE, USER REPORTED THAT THE DURING AN ANTERIOR LAPAROSCOPY AND COLONOSCOPY PROCEDURE, PATIENT SUSTAINED DEEP BURNS IN THE SMALL BOWEL. AS A RESULT, THEY FOUND 3 BURN AREAS INSIDE THE SMALL BOWEL, AND HAD TO RESECT PART OF SMALL BOWEL, PLUS STAPLE AND ANASTOMOSIS.

  Patient problems: Bowel Burn

  MAUDE report 14679939 ↗