AESCULAP GK384RRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04038653172504), received between Oct 6, 2020 and Sep 27, 2024 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2024Thermal Decomposition of Device; Scratched Material; Thermal Decomposition of Device; Scratched Material

  IT WAS REPORTED TO AESCULAP INC. THAT A CERAMIC ELECTRODE TIP L-HK F/GK372R (PART # GK384R) WAS USED DURING A LAPAROSCOPIC PROCEDURE ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE L HOOK USED DURING THE SURGERY BURNED THE DUODENUM IN TWO (2) PLACES. ADDITIONAL INFORMATION RECEIVED ON AUGUST 30 2024 REPORTED THAT THE PATIENT REQUIRED SUTURES. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). 2916714-2024-00144 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00145 (AIC REFERENCE NO. (B)(4)).

  Patient problems: Bowel Burn

  MAUDE report 20326311 ↗
• InjuryMay 21, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP INC. THAT A CERAMIC ELECTRODE TIP L-HK F/GK372R (PART # GK384R) WAS USED DURING A LAPAROSCOPIC PROCEDURE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THE TIP OF DEVICE BROKE OFF INTO PATIENT. REPORTEDLY THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PART. A SURGERY DELAY OF A FEW MINUTES WAS REPORTED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19361372 ↗
• InjurySep 19, 2023Break; Break

  INVESTIGATION COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773802 ↗
• MalfunctionSep 30, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A CERAMIC ELECTRODE TIP (PART # GK384R) WAS TO BE USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, PRIOR TO SURGERY, THE DEVICE WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT HARM. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: (B)(4) (9610612-2021-00731) GK384R - BROKEN DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513761 ↗
• MalfunctionNov 22, 2021Material Fragmentation; Material Fragmentation

  UPDATE: THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORT: 400533866 (9610612-2022-00265) GK384R - FOUND BROKEN PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12854908 ↗
• MalfunctionOct 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GK384R - CERAMIC ELECTRODE TIP L-HK F/GK372R. ACCORDING TO THE COMPLAINT DESCRIPTION, THE INSTRUMENT BROKE DURING LAPAROSCOPIC CHOLECYSTECTOMY SURGERY. THE L- HOOK BROKE DURING SURGERY; AND THE BREAKAGE WAS NOT FOUND UNTIL THE INSTRUMENT MADE IT TO STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657100 ↗
• MalfunctionAug 24, 2021Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED TO AESCULAP AG THAT A CERAMIC ELECTRODE TIP L-HK F/GK372R (PART # GK384R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, SPARKS WERE OBSERVED NEAR THE HOOK ELECTRODE. DURING USE WITH VIO30W, A SPARK CAME OUT FROM THE ROOT NEAR THE FITTING OF THE HOOK ELECTRODE. ACCORDING TO THE TEST RESULTS FROM A HOSPITAL SCAN, ONLY THE L-SHAPED NON-INSULATED PART AT THE TIP MAKES NOISE AND IS INSULATED, BUT THAT IS EXACTLY WHERE THE SPARKS WERE OBSERVED. OBSERVATION WITH A LOUPE SHOWED THAT THE HOOK WAS SCRATCHED, BUT NO PEELING OF THE INSULATION WAS FOUND, AND THE DEFORMATION OF THE TIP OF THE INSULATION PART OF THE HANDLE WAS CAUSED BY THE SPARK. REPORTEDLY, THE DEVICE WAS INSPECTED BEFORE EACH USE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363207 ↗
• MalfunctionAug 4, 2021Break; Material Fragmentation; Material Fragmentation

  THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4); CC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12275009 ↗
• InjuryApr 21, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED TO AESCULAP INC. THAT A THAT THERE WAS AN ISSUE WITH A CERAMIC ELECTRODE TIP (PART # GK384R) WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, NEAR THE END OF THE PROCEDURE, THE INNER METAL POST DETACHED. REPORTEDLY, WHILE THE SURGEON WAS REMOVING THE GALLBLADDER FROM THE LIVERBED, THE ELECTRODE TIP SEPARATED INTO TWO (2) PIECES. THE FRAGMENTS DETACHED INTO THE PATIENT, AND WERE RETRIEVED FROM THE SURGICAL FIELD USING A LAPAROSCOPIC GRASPER. THERE WAS LESS THAN A FIVE MINUTE DELAY DUE TO THE INCIDENT. THE SURGERY WAS COMPLETED USING ANOTHER AESCULAP MONOPOLAR INSTRUMENT. THE COMPLAINT DEVICE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703967 ↗
• InjuryApr 19, 2021Break; Fracture; Break; Fracture

  AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686225 ↗
• InjuryMar 24, 2021Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GK384R - CERAMIC ELECTRODE TIP L-HK F/GK372R. ACCORDING TO THE COMPLAINT DESCRIPTION, THAT THE CERAMIC ELECTRODE TIP HAD BECOME DETACHED INSIDE A PATIENT DURING AN OPERATION. IT IS NOT KNOWN IF THE DEVICE FRAGMENT WAS RECOVERED. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11561424 ↗
• InjuryMar 24, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO AESCULAP INC. THAT A CERAMIC ELECTRODE TIP L-HK F/GK372R (PART # GK384R) WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, AT THE BEGINNING OF THE CASE, THE CAUTERIZER HOOK WAS FOUND TO BE MISSING. X-RAYS WERE PERFORMED TO DETERMINE IF THE HOOK WAS RETAINED IN THE PATIENT. REPORTEDLY, A SURGICAL DELAY OCCURRED AS A RESULT OF THE X-RAYS THAT WERE PERFORMED. NO EVIDENCE THAT THE FRAFMENT WAS RETAINED INSIDE THE PATIENT. ALTHOUGH AVAILABLE, THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CERAMIC ELECTRODE TIP HAD DISENGAGED INSIDE A PATIENT DURING AN OPERATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4).

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

  MAUDE report 11561324 ↗
• InjuryOct 30, 2020Break; Break

  IT WAS REPORTED TO AESCULAP THAT A CERAMIC ELECTRODE TIP (PART # GK384R) WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. THE PHYSICIAN REPORTED THAT THE TIP OF THE L HOOK BROKE OFF DURING SURGERY. ACCORDING TO THE COMPLAINANT, APPROXIMATELY MIDWAY THROUGH THE PROCEDURE, WHILE THE SURGEON CUT AND MOVED TISSUE TO ACCESS THE DUCT AND ARTERY THAT REQUIRED CLIPPING, THE TIP OF THE L HOOK DETACHED INTO THE PATIENT. ALTHOUGH THE TIP WAS RETRIEVED FROM THE PATIENT, AN ABDOMINAL X-RAY WAS PERFORMED. REPORTEDLY, THE X-RAY DISPLAYED A METAL FRAGMENT WITHIN THE PATIENT'S ABDOMEN. A SEARCH OF THE SURGICAL SITE WAS PERFORMED, BUT THE FRAGMENT WAS NOT ABLE TO BE LOCATED. THE DEVICE IS NOT CURRENTLY AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SURGERY WAS DELAYED APPROXIMATELY ONE (1) HOUR. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4) REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10764760 ↗
• InjuryOct 30, 2020Break; Break

  INFORMATION RECEIVED VIA MW # (B)(4): PATIENT DATA: FEMALE, 25 YEARS OLD. THE SURGEON REMOVED DEVICE FROM CAUTERY HOLSTER AND USED LAPAROSCOPICALLY. THE TIP WAS IMMEDIATELY NOTED TO BE MISSING. THE WOUND AND FIELD WERE EXPLORED AND BROKEN TIP WAS FOUND INSIDE THE HOLSTER (OUTSIDE THE PATIENT'S BODY). THE PARTS WERE COMPARED TO A COMPLETE L-HOOK AND APPEARED TO MATCH. AN X-RAY WAS TAKEN TO VERIFY THAT ALL PIECES HAD BEEN REMOVED AND THERE WAS A VERY SMALL FRAGMENT VISIBLE ON THE X-RAY; IT WAS NOT VERIFIED IF THIS WAS PART OF THE TIP OR FRAGMENT BECAUSE IT WAS NOT LOCATED AT A SITE THAT HAD BEEN OPERATED ON (PREVIOUSLY DURING SURGERY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10764688 ↗
• InjuryOct 6, 2020Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A CERAMIC ELECTRODE. ACCORDING TO THE COMPLAINT DESCRIPTION THE L- HOOK OF THE DEVICE CAME OFF AT THE TIP BASE DURING SURGERY. THE MALFUNCTION OCCURRED DURING CAUTERIZATION IN A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH). THE TIP FELL INTO THE SURGICAL FIELD, AND WAS THEN REMOVED FROM THE PATIENT'S BODY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY FOR RETRIEVAL OF THE BROKEN PART. THIS EVENT PROLONGED THE PROCEDURE FOR 5-10 MINUTES. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER XC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10635425 ↗