n.a. 26775UFRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04048551072417), received between Jul 17, 2020 and Sep 8, 2026 — classified as 12 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (8 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Melted

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673648 ↗
• InjuryAug 14, 2026Detachment of Device or Device Component

  It was reported that during the coagulation phase of abdominal surgery, approximately 1-2 mm of the hook electrode broke off and was lost inside the patient.

  Patient problems: Foreign Body In Patient

  MAUDE report 50260032 ↗
• MalfunctionMay 22, 2026Sparking

  THE EVENT OCCURRED IN CANADA. ACCORDING TO THE INFORMATION RECEIVED, THE GYN NURSE LET MDRD KNOW THE L-HOOK WAS SPARKING AND SEEMED THERE WAS MISSING INSULATION AT THE TIP. IT PASSED CONTINUITY TESTING IN MDRD BEFORE BEING PUT INTO THE SET. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25259930 ↗
• InjuryMay 5, 2026Material Fragmentation

  DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TIP OF A SURGICAL HOOK FRACTURED AND REMAINED INSIDE THE PATIENT. AN X-RAY WAS PERFORMED IN AN ATTEMPT TO LOCATE THE FRAGMENT. HOWEVER, THE FRAGMENT COULD NOT BE LOCATED, LIKELY DUE TO ITS VERY SMALL SIZE. SINCE A FRAGMENT REMAINS INSIDE THE PATIENT BODY AND X-RAYS WERE TAKEN, THIS CASE DEEMED BE REPORTABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25086692 ↗
• MalfunctionApr 27, 2026Material Puncture/Hole

  IT WAS REPORTED THAT "THE NEEDLE HOLDER DOES NOT GRIP PROPERLY, AND THE ELECTRODE HAS A DAMAGED INSULATED SECTION." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001752 ↗
• MalfunctionMar 5, 2026Overheating of Device

  THE EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE L-HOOK BEING USED DURING CASE WHEN INSULATING RUBBER ON END OF HOOK APPEARED TO LOOK BURNT/FRAYED AND STARTED TO PEEL BACK. SITE WAS SURPRISED SINCE L-HOOK WAS INSPECTED PRIOR TO USE. SOME INTERFERENCE WITH THE VIDEO WAS ALSO NOTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524007 ↗
• MalfunctionJan 28, 2026Break

  THE EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THERE WAS AN ISSUE IN THE OR WHERE THE L-TIP BROKE DURING USE. IT WAS CONFIRMED THAT THE L-TIP WAS REMOVED FROM THE PATIENT AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH A BACKUP. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203099 ↗
• MalfunctionJan 7, 2026Arcing

  IT WAS REPORTED UNINTENDED ELECTRICAL ARCING DURING SURGERY. ACCORDING TO THE AVAILABLE INFORMATION THERE WERE NO ADVERSE CONSEQUENCES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991551 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE THE END PART OF THE MEDICAL DEVICE WAS BROKE WHILST TAKING OUT A FIBROID. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073930 ↗
• InjuryJul 8, 2025Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT THE TIP BROKE OFF DURING PROCEDURE. THE DIATHERMY HOOK WAS USED INSIDE THE LEFT PLEURA AND WAS GIVEN BACK WITH THE MISSING TIP, THE SURGEON WAS INFORMED RIGHT AWAY. THE SURGEON CHECKED THE CAVITY AND FOUND NOTHING. SCRUB TEAM SEARCHED, BUT NOTHING WAS FOUND. AN XRAY WAS PERFORMED AND CONFIRMED BY THE SURGEON, SHOWING NOTHING PRESENT INSIDE. HOWEVER, THE BROKEN OFF TIP OF THE DIATHERMY HOOK (APPROXIMATELY 5MM IN LENGTH) WAS NOT FOUND AND X-RAYS WERE TAKEN.

  Patient problems: Insufficient Information

  MAUDE report 22448924 ↗
• InjuryJul 8, 2025Break; Material Fragmentation; Overheating of Device; Use of Device Problem; Component Missing; Break; Material Fragmentation; Overheating of Device; Use of Device Problem; Component Missing

  IT WAS REPORTED THAT THE TIP BROKE OFF DURING PROCEDURE. THE DIATHERMY HOOK WAS USED INSIDE THE LEFT PLEURA AND WAS GIVEN BACK WITH THE MISSING TIP, THE SURGEON WAS INFORMED RIGHT AWAY. THE SURGEON CHECKED THE CAVITY AND FOUND NOTHING. SCRUB TEAM SEARCHED, BUT NOTHING WAS FOUND. AN XRAY WAS PERFORMED AND CONFIRMED BY THE SURGEON, SHOWING NOTHING PRESENT INSIDE. HOWEVER, THE BROKEN OFF TIP OF THE DIATHERMY HOOK (APPROXIMATELY 5MM IN LENGTH) WAS NOT FOUND AND X-RAYS WERE TAKEN.

  Patient problems: Insufficient Information

  MAUDE report 22448888 ↗
• MalfunctionFeb 19, 2025Material Fragmentation; Overheating of Device; Use of Device Problem; Insufficient Device Problem Information; Material Fragmentation; Overheating of Device; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE COAGULATING AND DISSECTING ELECTRODE HAS INSULATION PROBLEMS. THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. CROSS REFERENCE MEDWATCH 9610617-2025-00236, CROSS REFERENCE MEDWATCH 9610617-2025-00239.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411733 ↗
• MalfunctionFeb 19, 2025Overheating of Device; Insufficient Device Problem Information; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE COAGULATING AND DISSECTING ELECTRODE HAS INSULATION PROBLEMS. THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. CROSS REFERENCE MEDWATCH 9610617-2025-00236. CROSS REFERENCE MEDWATCH 9610617-2025-00240.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411728 ↗
• MalfunctionFeb 19, 2025Flaked; Overheating of Device; Use of Device Problem; Flaked; Overheating of Device; Use of Device Problem

  THE EVENT OCCURRED IN CANADA. IT WAS REPORTED: PROBLEM OF INSULATION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MEDWATCH: 9610617-2025-00239, CROSS REFERENCE MEDWATCH: 9610617-2025-00240.

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

  MAUDE report 21411725 ↗
• InjuryNov 7, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY BILATERAL SALPINGO OOPHORECTOMY WITH BOWEL ADHESIOLYSIS. LAP HOOK WAS USED INTRA-OPERATIVELY AND TIP OF THE HOOK WAS FOUND BROKEN ON THE LAPAROSCOPIC TV SCREEN WHILE USING BY THE SURGICAL TEAM. A THOROUGH SEARCH WAS PERFORMED BUT TO NO AVAIL AS THE TIP THAT WAS CHIPPED OFF WAS TOO SMALL. INTRA-OPERATIVE X-RAYS WERE ORDERED TO LOCATE FOR THE MISSING HOOK TIP. TIP WAS FINALLY FOUND AT THE END OF THE SURGERY THROUGH X-RAY IN THE SPECIMEN PIECES. THIS INCIDENT RESULTED IN THE PATIENT UNDERGOING LONGER THAN USUAL GENERAL ANAESTHESIA AND ADDITIONAL X-RAY SCREENINGS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20636570 ↗
• InjuryNov 7, 2024Material Fragmentation; Overheating of Device; Use of Device Problem; Material Fragmentation; Overheating of Device; Use of Device Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY BILATERAL SALPINGO OOPHORECTOMY WITH BOWEL ADHESIOLYSIS. LAP HOOK WAS USED INTRA-OPERATIVELY AND TIP OF THE HOOK WAS FOUND BROKEN ON THE LAPAROSCOPIC TV SCREEN WHILE USING BY THE SURGICAL TEAM. A THOROUGH SEARCH WAS PERFORMED BUT TO NO AVAIL AS THE TIP THAT WAS CHIPPED OFF WAS TOO SMALL. INTRA-OPERATIVE X-RAYS WERE ORDERED TO LOCATE FOR THE MISSING HOOK TIP. TIP WAS FINALLY FOUND AT THE END OF THE SURGERY THROUGH X-RAY IN THE SPECIMEN PIECES. THIS INCIDENT RESULTED IN THE PATIENT UNDERGOING LONGER THAN USUAL GENERAL ANAESTHESIA AND ADDITIONAL X-RAY SCREENINGS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20635613 ↗
• InjuryAug 22, 2024Break; Break

  IT WAS REPORTED THAT DAMAGE RUBBER OF DISTAL TIP LAPAROSCOPY DISSECTING ELECTRODE AND THIS PIECE WAS PROBABLY LEFT INSIDE PATIENT. NEW TOOL WAS DELIVER TO CONTINUE OPERATION. X-RAY WERE TAKEN BUT THE BROKEN PIECE WAS NOT FOUND. DUE TO THE POT. FRAGMENT IN SITU THE EVENT IS REPORTABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20034811 ↗
• InjuryAug 22, 2024Break; Overheating of Device; Use of Device Problem; Break; Overheating of Device; Use of Device Problem

  IT WAS REPORTED THAT DAMAGE RUBBER OF DISTAL TIP LAPAROSCOPY DISSECTING ELECTRODE AND THIS PIECE WAS PROBABLY LEFT INSIDE PATIENT. NEW TOOL WAS DELIVER TO CONTINUE OPERATION. X-RAY WERE TAKEN BUT THE BROKEN PIECE WAS NOT FOUND. DUE TO THE POT. FRAGMENT IN SITU THE EVENT IS REPORTABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20033379 ↗
• MalfunctionMay 16, 2024Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT THE MATERIALS REPORTED IN THIS CASE HAVING ISSUE THAT THE TIP OF THE LAPAROSCOPIC HOOK BROKE DURING A PROCEDURE AND 1-3MM OF THIS FRAGMENT IS NOW RETAINED IN THE PATIENT. THE SURGEON DECIDED TO USE THE THORACOSCOPIC DIATHERMY TO DO THIS AFTER THE HARMONIC STOPPED WORKING. DURING THE CUTTING, THE TIP OF THE HOOK BROKE OFF AND WAS LOST IN THE THORACIC CAVITY. IT WAS LOOKED FOR THORACOSCOPICALLY AND COULD NOT BE FOUND AT THE TIME USING II, IT HAS HOWEVER BEEN SEEN ON A POST-OP PLAIN FILM.

  Patient problems: Foreign Body In Patient

  MAUDE report 19333249 ↗
• InjuryApr 18, 2024Melted; Melted

  THE INCIDENT OCCURRED DURING THE PROCEDURE, CAUSING THE SHEATH TO MELT AND RESULTING IN BURNS TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 19135505 ↗
• InjuryApr 18, 2024Melted; Overheating of Device; Use of Device Problem; Dent in Material; Melted; Overheating of Device; Use of Device Problem; Dent in Material

  THE INCIDENT OCCURRED DURING THE PROCEDURE, CAUSING THE SHEATH TO MELT AND RESULTING IN BURNS TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 19135504 ↗
• InjuryJun 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS BURNT IN AN INCIDENT. NO FURTHER INFORMATION WAS PROVIDED ABOUT THE EVENT.

  Patient problems: Burn(s)

  MAUDE report 17109704 ↗
• MalfunctionJun 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS BURNT IN AN INCIDENT. NO FURTHER INFORMATION WAS PROVIDED ABOUT THE EVENT.

  Patient problems: Burn(s)

  MAUDE report 17109687 ↗
• MalfunctionJun 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS EVENT WITH 26775UF COAGULATING AND DISSECTING ELECTRODE. ACCORDING TO THE INFORMATION RECEIVED FROM THE FACILITY THE ELECTRODE "BURNS THE PATIENT". THERE WAS NO BURN MARK OR LEISON LEFT ON THE PATIENT PER FACILITY AS OF THE DATE OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17078126 ↗
• InjuryMay 27, 2021Break; Break

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): AS REPORTED: DURING A LAPAROSCOPIC APPENDICECTOMY A DIATHERMY TIP (26775UF) BROKE AWAY WHILST INSIDE THE PATIENT. THE INCIDENT HAPPENED ON THURSDAY (15/04). THE CONSULTANT TOOK THE FOLLOWING STEPS TO FIND THE MISSING TIP BUT WAS UNSUCCESSFUL. AS IT STANDS THE LOCATION OF THE TIP IS STILL UNKNOWN. CHECKED PELVIC AREA, CHECKED PORTS AND DRAPES, CHECKED FLOOR, X - RAY WAS CALLED TO THEATRES HOWEVER THE TIP WASN'T FOUND, WASH OUT OF THE ABDOMEN. AFTER THE PROCEDURE THE PATIENT WAS INFORMED OF THE INCIDENT. REMAINING PART OF DEVICE DISPOSED OF IN SHARPS BIN"

  Patient problems: Foreign Body In Patient

  MAUDE report 11895906 ↗