AESCULAP GK383RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04038653172498), received between Dec 1, 2020 and Oct 15, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Break; Break

  ACCORDING TO MW5175620: FOLLOWING THE END OF THE TOTAL LAP HYSTERECTOMY, BILATERAL SALPINGECTOMY, LYSIS OF ADHESIONS, AND AFTER THE REMOVAL OF THE J HOOK THE LIP WAS NOTED TO BE MISSING. CAREFUL SUCTION AND INSPECTION OF THE ABDOMEN AND PELVIS WAS DONE HOWEVER THE LIP WAS NOT ENCOUNTERED. INTRA OPERATIVE ABDOMINAL AND PELVIC X RAYS WERE DONE AND THE IMAGES REVIEWED WITH RADIOLOGY REAL TIME. THE X-RAYS WERE NOTED TO BE NORMAL SHOWING THE UTERINE MANIPULATOR (WHICH WAS STILL IN PLACE AS WE HAD NOT COMPLETED THE COLPOTOMY) BUT NO TIP OF THE J HOOK. THE SUCTION WAS INSPECTED AND DRAINED. THE PORTS WERE CHANGED. THE TIP WAS NOT ENCOUNTERED. SINCE THE X-RAY WAS NORMAL, WE COMPLETED THE COLPOTOMY WITH A NEW HOOK WITHOUT COMPLICATION. THE UTERUS AND CERVIX WERE REMOVED VAGINALLY. THE UTERUS AND CERVIX WERE ALSO INSPECTED AND THE TIP WAS NOT ENCOUNTERED. ALL INSTRUMENTS WERE REMOVED AND THE GAS ALLOWED TO ESCAPE. THE SKIN WAS CLOSED WITH 3-0 VICRYL IN A SUBCUTICULAR FASHION AND DERMABOND. THE DRAPES, GOWNS, SHOE COVERS WERE INSPECTED CAREFUL. THE BROKEN TIP OF THE J HOOK WAS ENCOUNTERED UNDER THE DRAPE NEXT TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23292142 ↗
• MalfunctionApr 16, 2021Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GK383R - CERAMIC ELECTRODE TIP J-HK F/GK372R. ACCORDING TO THE COMPLAINT DESCRIPTION, THE HOOK INSULATION FAILED DURING SURGERY. DURING A LAPAROSCOPIC PROCEDURE THERE WAS BLEEDING AND THE CURRENT CAUTERY SETTING WAS NOT EFFECTIVE IN CONTROLLING THE BLEEDING; THEN, THE CAUTERY SETTING WAS INCREASED. IT WAS NOT NOTICED UNTIL THE END OF THE CASE, WHEN THE INSTRUMENTS WERE TAKEN TO DECONTAMINATION, THAT THERE WAS AN ISSUE WITH THE INSULATION; WHICH HAD APPEARED TO BE MELTED. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11678916 ↗
• InjuryDec 1, 2020Break; Break

  NO UPDATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928799 ↗
• InjuryDec 1, 2020Break; Break

  IT WAS REPORTED TO AESCULAP INC. THAT A CERAMIC ELECTRODE TIP (PART # GK383R) WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, CERAMIC INSULATION WAS OBSERVED TO BE MISSING FROM THE SHAFT, NEAR THE DISTAL TIP OF THE DEVICE. HOWEVER, THE DAMAGE WAS NOT IDENTIFIED BY THE SURGICAL STAFF UNTIL THE DEVICE WAS ON THE BACK TABLE, SO NO DETERMINATION COULD BE MADE AS TO WHEN THE DAMAGE OCCURRED. AN X-RAY WAS PERFORMED, BUT NO FRAGMENTS WERE IDENTIFIED. ADDITIONALLY, THE SURGICAL STAFF CHECKED THE PATIENT, AND CONFIRMED THAT NO PIECES WERE PRESENT. THE SURGERY WAS DELAYED FOR AN UNSPECIFIED AMOUNT OF TIME DUE TO THE X-RAYS THAT WERE PERFORMED. THE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928780 ↗