AESCULAP US354Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04046964582820), received between Oct 27, 2020 and Feb 5, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Sparking” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Break; Sparking

  ACCORDING TO THE COMPLAINANT: "THE US354 MONOPOLAR CORD WAS PLUGGED INTO THE POWER SOURCE IN THE OPERATING ROOM. THE OPERATING ROOM TEAM HURT A 'POP' AND THE CORD WAS BROKEN INTO TWO PIECES. THIS IS NOT A NEW CORD, NOR COULD WE TELL HOW OLD IT WAS BECAUSE THE LOT NUMBER IS NOT ON THE ACTUAL CORD, JUST THE PACKAGING, BUT IT WAS NOT NEW." A DELAY OF THREE MINUTES WAS ALSO REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269437 ↗
• MalfunctionJun 13, 2025Fire; Fire

  IT WAS REPORTED TO AESCULAP INC. THAT A MONOPOLAR CABLE W/LG PIN, 10 FEET (PART# US354) WAS USED DURING A PROCEDURE ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT THE CORD STARTED A FIRE DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201857 ↗
• MalfunctionJun 6, 2025Sparking; Sparking

  IT WAS REPORTED TO AESCULAP INC. THAT A BIPOLAR FCPS RNDMICROSTR .7MM153MM (PART # US345) WAS USED DURING A LAPAROSCOPIC ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT THE CHORD WAS BROKE WHILE PLUGGED IN. REPORTEDLY THE STAFF CAUGHT BIT OF CORD THAT SPARKED THERE WAS NO INJURY, FIRE OR DELAY OF CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158037 ↗
• MalfunctionJun 2, 2025Smoking; Smoking

  AS REPORTED BY THE USER FACILITY: REPORTED THAT THE SURGEON NOTICED THAT THE CABLE STARTED SMOKING AND STAFF SAID IT BECAME HOT TO TOUCH. THIS IS REPORTED AFTER ONLY HAVING THE CABLE FOR AROUND 3 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122302 ↗
• MalfunctionOct 6, 2023Break; Sparking; Break; Sparking

  INVESTIGATION COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884978 ↗
• MalfunctionAug 15, 2023Smoking; Sparking; Smoking; Sparking

  IT WAS REPORTED TO AESCULAP INC. THAT A MONOPOLAR CABLE W/LG PIN, 10 FEET (PART # US354) WAS USED DURING A PROCEDURE ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE ITEM GLOWED AND SMOKED BUT THERE WAS NO VISUAL SIGN OF DAMAGE. A DELAY IN SURGERY WAS REPORTED BUT NOT SPECIFIED HOW LONG. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548906 ↗
• MalfunctionMay 24, 2023Sparking; Sparking

  INVESTIGATION COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 16994710 ↗
• MalfunctionJan 3, 2023Sparking; Sparking

  IT WAS REPORTED TO AESCULAP INC. THAT A MONOPOLAR CABLE W/LG PIN, 10 FEET (ITEM # US354) WAS USED IN A CASE ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SURGICAL TECHNICIAN ADDED THE CORD TO THE DEVICE, AND THEN THE SURGEON PLACED IN POSITION AND STEPPED ON THE FOOT PEDAL. REPORTEDLY, THE DEVICE IMMEDIATELY POPPED, WITH SMOKE AND FLAMES OBSERVED. THE CORD FELL FROM THE HUB. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086361 ↗
• MalfunctionNov 29, 2022Sparking; Sparking

  INVESTIGATION COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877301 ↗
• InjuryAug 30, 2021Sparking; Sparking

  WHILE THE SURGEON WAS CAUTERIZING LAPAROSCOPICLY CHOLECYSTECTOMY, THE PROCEDURE WAS STOPPED FOR 15-20 MINUTES, WHILE EQUIPMENT WAS EXCHANGED.

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

  MAUDE report 12387714 ↗
• MalfunctionMar 10, 2021Sparking; Sparking

  IT WAS REPORTED THAT THE MONOPOLAR CABLE W/LG PIN, 10 FEET MALFUNCTIONED DURING A PROCEDURE. THE PRODUCT STARTED "SPARKING" AND THE ISSUE WAS NOTICED QUICKLY. A BACK-UP DEVICE WAS READILY AVAILABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A SHORT SURGICAL DELAY (A COUPLE OF MINUTES). AN ADDITIONAL MEDICAL INTERVENTION WAS NOT REQUIRED AND THERE WAS NO HARM TO THE PATIENT OR STAFF. IN THE PRE-CHECK PREOPERATIVELY, THE NURSE HAD NOTED THAT THE CORD WAS WITHOUT NICKS OR FRAYED WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456771 ↗
• MalfunctionDec 22, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED TO AESCULAP THAT A MONOPOLAR CABLE (PART # US354) WAS USED DURING A HERNIA REPAIR PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE CABLE, WHERE THE PLUG OF THE BOVIE CONNECTED TO THE CORD, COMPLETELY BURNED UP AND SEPARATED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS OR SURGICAL DELAY OCCURRED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11059336 ↗
• MalfunctionOct 27, 2020Disconnection; Disconnection

  ADDITIONAL INFORMATION WAS RECEIVED VIA MW5097096: DURING THE PROCEDURE, THERE WAS A BREAK IN THE MONOPOLAR BOVIE CORD. THIS WAS APPROXIMATELY 2 INCHES FROM THE END THAT CONNECTS THE CORD TO THE HOOK CAUTERY. THE CORD WAS HOT TO THE TOUCH AND GLOWED ORANGE. THERE WAS NO PATIENT OR EMPLOYEE INJURY. ("SERIOUS INJURY" HAD BEEN CHECKED OFF ON THE FORM, BUT AN INJURY NOR INTERVENTION WERE NOTED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10742119 ↗