n.a. 26006MRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04048551090916), received between Jun 21, 2022 and Mar 6, 2026 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Sparking” (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

Recent adverse event reports

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

• MalfunctionMar 6, 2026Sparking

  IT WAS REPORTED THAT CONNECTED WITH A MONOPOLAR L-HOOK, IT SUDDENLY PRODUCED SPARKS INSIDE THE OPERATING THEATER, AND THE CABLE WAS DAMAGED AND DISCONNECTED DUE TO THE SPARKS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539479 ↗
• MalfunctionJan 30, 2026Fire

  IT WAS REPORTED THAT "DIATHERMY CABLE CAUGHT FIRE DURING VAFT PROCEDURE.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24225424 ↗
• MalfunctionAug 23, 2024Arcing; Sparking; Material Split, Cut or Torn; Arcing; Sparking; Material Split, Cut or Torn

  IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2024, THE SURGICAL TECH STATED THE UNIPOLAR HIGH FREQUENCY CORD SPARK AND THE CORD DETACHED FROM THE ADAPTER. HOWEVER, NO INJURIES WERE REPORTED TO THE PATIENT OR THE SURGERICAL STAFF.

  Patient problems: Insufficient Information

  MAUDE report 20054306 ↗
• MalfunctionAug 6, 2024Material Deformation; Insufficient Device Problem Information; Explosion; Material Deformation; Insufficient Device Problem Information; Explosion

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2024, THE UNIPOLAR HIGH FREQUENCY CORD THAT ATTACHES TO THE L HOOK POPPED, BURNED STRAIGHT THROUGH AND THEN CAME OFF THE REST OF THE CABLE. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH A BACK-UP CORD. NO PATIENT INJURY WAS REPORTED. HOWEVER THIS CAUSED A DELAY TO THE CASE OF LESS THAN 2 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923744 ↗
• MalfunctionAug 6, 2024Break; Sparking; Break; Sparking

  IT WAS REPORTED DURING A GALL BLADDER PROCEDURE ON (B)(6) 2024, THE UNIPOLAR HIGH FREQUENCY CORD SPARKED AND BROKE OFF AT THE PROXIMAL END WHILE THE DOCTOR WAS ATTEMPING TO CAUTERIZE. HOWEVER, NO INJURIES WERE REPORTED AND NO SURGICAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923608 ↗
• InjuryAug 5, 2024Electrical /Electronic Property Problem; Flare or Flash; Electrical /Electronic Property Problem; Flare or Flash

  IT WAS REPORTED THAT PROCEDURE ON (B)(6) 2024, THE UNIPOLAR HIGH FREQUENCY CORD CAUGHT FIRE DURING THE CASE. THE CORD MELTED OFF AT THE CONNECTING PIECE THAT GOES INTO THE ELECTROCAUTERY MACHINE. A SALINE SOAKED TOWEL WAS PLACED OVER THE VERY SMALL FLAME AND IT WAS THEN EXTINGUISHED. A BACK-UP ELECTROCAUTERY MACHINE AND NEW CORD WERE BROUGHT IN TO COMPLETE THE CASE. NO USER OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19914465 ↗
• InjuryAug 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PROCEDURE ON (B)(6) 2024, THE UNIPOLAR HIGH FREQUENCY CORD CAUGHT FIRE DURING THE CASE. THE CORD MELTED OFF AT THE CONNECTING PIECE THAT GOES INTO THE ELECTROCAUTERY MACHINE. A SALINE SOAKED TOWEL WAS PLACED OVER THE VERY SMALL FLAME AND IT WAS THEN EXTINGUISHED. A BACK-UP ELECTROCAUTERY MACHINE AND NEW CORD WERE BROUGHT IN TO COMPLETE THE CASE. NO USER OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19914464 ↗
• MalfunctionJul 9, 2024Failure to Conduct; Sparking; Failure to Conduct; Sparking

  IT WAS REPORTED THAT THE DIATHERMY LEADS SPARKED AND LOST ALL CURRENT WHILE IN USE. NO ONE WAS HURT AND IT WAS FAR AWAY FROM THE PATIENT. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706930 ↗
• MalfunctionJul 9, 2024Failure to Conduct; Sparking; Failure to Conduct; Sparking

  IT WAS REPORTED THAT THE DIATHERMY LEADS SPARKED AND LOST ALL CURRENT WHILE IN USE. NO ONE WAS HURT AND IT WAS FAR AWAY FROM THE PATIENT. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706896 ↗
• MalfunctionJul 9, 2024Crack; Sparking; Detachment of Device or Device Component; Crack; Sparking; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PIECE OF THE HOOK INSTRUMENT "SPARKED" AND HAD BROKEN OFF WITHIN THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED. NO HARM TO PATIENT, USER OR THIRD PARTIES REPORTED. HOWEVER, DUE TO THE REPORTED SPARK AS WELL AS THE BROKEN OFF PIECE WITHOUT INFORMATION ABOUT THE OUTCOME, THIS CASE IS DEEMED REPORTABLE FOR PRECAUTIONARY REASONS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705431 ↗
• MalfunctionApr 10, 2024Fire; Flare or Flash; Fire; Flare or Flash

  IT WAS REPORTED THAT THE UNIPOLAR HIGH FREQUENCY CORD SPARKED AND CAUGHT FIRE DURING THE SURGERY. WHILE USING THE ELECTRODE TO CAUTERIZE, THE CENTER AREA OF THE CORD SPARKED AND CAUGHT SURGICAL DRAPE AND ARM CRADLE FOAM PADDING ON FIRE. A SMALL AMOUNT OF WATER WAS USED TO EXTINGUISH THE FIRE. THE PATIENT SUSTAINED A BURN ON HE INNER LEFT FOREARM AND ALSO SEVERAL SPOTS ON THE LEFT SIDE OF ABDOMEN.

  Patient problems: Bowel Burn; Burn(s)

  MAUDE report 19085265 ↗
• MalfunctionOct 17, 2023Separation Failure; Flare or Flash; Separation Failure; Flare or Flash

  IT WAS REPORTED THAT THE CORD HAD DETACHED FROM THE PLUG AND THE LIVE WIRE HAD BURNT THE GOWN OF THE SURGEON. ANOTHER CORD HAD BEEN BROUGHT IN AND THE PROCEDURE COULD HAVE BEEN COMPLETED. THE PATIENT AND THE SURGEON WERE UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953754 ↗
• InjuryJul 20, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT HEAT BURNT THROUGH CORD AT PROXIMAL END, POSSIBLY BURNED PATIENT.

  Patient problems: Burn(s)

  MAUDE report 17364253 ↗
• InjuryJul 20, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT HEAT BURNT THROUGH CORD AT PROXIMAL END, POSSIBLY BURNED PATIENT.

  Patient problems: Burn(s)

  MAUDE report 17363956 ↗
• MalfunctionMar 9, 2023Fire; Fire

  IT WAS REPORTED THAT THERE WAS AN EVENT WITH A 26006M MONOPOLAR HIGH FREQUENCY CORD. ACCORDING TO THE INFORMATION RECEIVED, DURING A TURB PROCEDURE, THERE WAS AN APPARENT BREAKAGE AT THE NECK OF HEADPIECE THAT CONNECTS TO BOVIE PLUGIN, JOINT WHERE HANDPIECE CONNECTS TO CABLE. FLAMES WERE SEEN COMING FROM THE MONOPOLAR BUGBY CORD WHILE IN USE. THERE WAS NO HARM TO PATIENT OR TO USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511402 ↗
• MalfunctionDec 29, 2022Electrical Overstress; Electrical Overstress

  THE EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT DURING A SLEEVE GASTROSCOPY SURGERY, THE ELECTROSURGERY DEVICE CONNECTED TO THE GENERATOR WAS USED TO RESTRAIN HEMORRHAGE IN THE LAPAROSCOPIC ACCESS PORT. IN THE COURSE OF SUCH USE FIRST, INEFFECTIVENESS IN TRANSMITTING THE ELECTRICAL PULSE WAS DETECTED, AND SOON AFTER, A SHORT CIRCUIT IN THE CABLE WAS DETECTED, WHICH FORCED TO IMMEDIATELY SUSPEND THE PROCEDURE AND PROVIDE CABLE REPLACEMENT. NO HARM TO THE PATIENT, USER, OR THIRD REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16074595 ↗
• MalfunctionJun 21, 2022Fire; Fire

  PER THE FACILITY WHEN THE MONOPOLAR CORD WAS ACTIVATED THE OPERATING ROOM TEAM HEARD A "POP". THE CORD SEVERED AND FLIPPED ONTO THE PATIENT'S LEG DRAPE. A SMALL FLAME WAS NOTED, THE PATIENT WAS EXAMINED WITH NO INJURIES FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754398 ↗