n.a. 26775CRecalls & reported problems
Karl Storz GmbH & Co. KG · Coagulating and Dissecting Electrode · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04048551072288), received between Apr 17, 2020 and Sep 23, 2026 — classified as 3 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Melted” (5 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.
Reports received per month
Most reported problems
Device problems
- Melted5
- Sparking5
- Mechanical Problem4
- Product Quality Problem4
- Overheating of Device3
- Flare or Flash2
- Temperature Problem2
- Thermal Decomposition of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Consequences Or Impact To Patient4
- Burn(s)3
- Insufficient Information3
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Flare or Flash
Patient problems: Insufficient Information
MAUDE report 50876098 ↗MalfunctionSep 23, 2026Flare or Flash
Patient problems: Insufficient Information
MAUDE report 50876097 ↗InjuryMay 20, 2026Therapy Delivered to Incorrect Body Area
THE FOLLOWING WAS REPORTED: "DURING A LAPAROSCOPIC CHOLECYSTECOMY CASE, THE L-HOOK INSTRUMENT HAD AN UNEXPECTED ENERGY DISCHARGE UPON COAGULATION, RESULTING IN A MINIMAL SUPERFICIAL DENT/BURN TO A PATIENT'S UPPER LIVER BED TISSUE. THE INTENDED TARGET TISSUE FOR COAGULATION WAS THE LIVER BED WALL AT THE GALLBLADDER DISSECTION SITE; HOWEVER, THE ELECTRICAL OUTPUT APPEARED NOT TO REMAIN ISOLATED TO THE INTENDED TISSUE AND INSTEAD AFFECTED ADJACENT UPPER LIVER TISSUE. IT WAS ADDITIONALLY NOTED THAT THE BLACK PLASTIC OUTER SHEATH OF THE L-HOOK INSTRUMENT DEMONSTRATED EVIDENCE OF A BURNT SURFACE FOLLOWING USE. THE SURGEON COMPLETED HAEMOSTASIS SUCCESSFULLY AND CONFIRMED THAT THE LIVER BED WAS CLEAR OF BLEEDING. THE AFFECTED UPPER LIVER AREA APPEARED MINIMALLY BURNT WITHOUT SIGNIFICANT TISSUE DAMAGE. NO SIGNIFICANT BLEEDING OR FURTHER COMPLICATION WAS IDENTIFIED INTRAOPERATIVELY. THE PROCEDURE WAS OTHERWISE COMPLETED SAFELY, AND NO PATIENT HARM WAS IDENTIFIED. PATIENT WAS RECOVERED SAFELY AND SUBSEQUENTLY DISCHARGED. DUE TO AN UNEXPECTED DENT / BURN TO A PATIENT'S UPPER LIVER BED TISSUE, THE EVENT IS DEEMED REPORTABLE.
Patient problems: Burn(s)
MAUDE report 25234200 ↗MalfunctionFeb 19, 2026Thermal Decomposition of Device
IT WAS REPORTED THAT DEFECT WAS DETECTED AFTER SURGERY DURING INSTRUMENTS INSPECTION DURING CLEANING AND STERILIZATION. THE SURGERY WAS COMPLETED AND THERE WAS NO PROBLEM WITH PATIENT. THE PRELIMINARY INVESTIGATION REVEALS SHAFT DISTAL TEMPERATURE DAMAGED. ACCORDING TO PICTURES AVAILABLE, THE INSULATION IS DAMAGED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24392943 ↗MalfunctionFeb 19, 2026Thermal Decomposition of Device
IT WAS REPORTED THAT DEFECT WAS DETECTED AFTER SURGERY DURING INSTRUMENTS INSPECTION DURING CLEANING AND STERILIZATION. THE SURGERY WAS COMPLETED AND THERE WAS NO PROBLEM WITH PATIENT. THE PRELIMINARY INVESTIGATION REVEALS SHAFT DISTAL TEMPERATURE DAMAGED. ACCORDING TO PICTURES AVAILABLE, THE INSULATION IS DAMAGED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24392935 ↗MalfunctionAug 4, 2025Mechanical Problem; Defective Component; Material Integrity Problem; Temperature Problem; Mechanical Problem; Defective Component; Material Integrity Problem; Temperature Problem
IT WAS REPORTED THAT THE INSULATION DOES NOT HOLD. IT CRACKED. CURRENT ESCAPES FROM THE SIDES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 22701307 ↗MalfunctionMay 28, 2025Mechanical Problem; Temperature Problem; Mechanical Problem; Temperature Problem
IT WAS REPORTED DURING THE SURGERY, THE LEAKAGE OF ELECTRICITY HAPPENED. THE TIP OF THE 26775C WAS BURNED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22101449 ↗InjuryMay 15, 2025Mechanical Problem; Mechanical Problem
ACCORDING TO THE INFORMATION RECEIVED, SKIN BURNS DURING SURGERY. AS THERE IS NO MORE PRECISE INFORMATION ABOUT THE BURNING DEGREE THE CASE IS DEEMED REPORTABLE.
Patient problems: Burn(s)
MAUDE report 22031684 ↗InjuryMay 15, 2025Mechanical Problem; Overheating of Device; Excessive Heating; Mechanical Problem; Overheating of Device; Excessive Heating
ACCORDING TO THE INFORMATION RECEIVED, SKIN BURNS DURING SURGERY. AS THERE IS NO MORE PRECISE INFORMATION ABOUT THE BURNING DEGREE THE CASE IS DEEMED REPORTABLE.
Patient problems: Burn(s)
MAUDE report 22031683 ↗MalfunctionMar 8, 2024Melted; Sparking; Melted; Sparking
IT WAS REPORTED THAT "THE PROXIMAL PARTS ARE CHARRED, WHICH CREATES SPARKS DURING THEIR USE". ACCORDING TO FURTHER RECEIVED INFORMATION THERE WAS A SURGICAL DELAY OF LESS THAN 15 MINUTES, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO AFFECT ON A PATIENT, USER OR THIRD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870988 ↗MalfunctionMar 8, 2024Melted; Overheating of Device; Sparking; Melted; Overheating of Device; Sparking
IT WAS REPORTED THAT "THE PROXIMAL PARTS ARE CHARRED, WHICH CREATES SPARKS DURING THEIR USE". ACCORDING TO FURTHER RECEIVED INFORMATION THERE WAS A SURGICAL DELAY OF LESS THAN 15 MINUTES, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO AFFECT ON A PATIENT, USER OR THIRD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870987 ↗MalfunctionMar 8, 2024Melted; Sparking; Melted; Sparking
IT WAS REPORTED THAT "THE PROXIMAL PARTS ARE CHARRED, WHICH CREATES SPARKS DURING THEIR USE". ACCORDING TO FURTHER RECEIVED INFORMATION THERE WAS A SURGICAL DELAY OF LESS THAN 15 MINUTES, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO AFFECT ON A PATIENT, USER OR THIRD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870986 ↗MalfunctionMar 8, 2024Melted; Overheating of Device; Sparking; Melted; Overheating of Device; Sparking
IT WAS REPORTED THAT "THE PROXIMAL PARTS ARE CHARRED, WHICH CREATES SPARKS DURING THEIR USE". ACCORDING TO FURTHER RECEIVED INFORMATION THERE WAS A SURGICAL DELAY OF LESS THAN 15 MINUTES, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO AFFECT ON A PATIENT, USER OR THIRD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870985 ↗MalfunctionMar 8, 2024Melted; Sparking; Melted; Sparking
IT WAS REPORTED THAT "THE PROXIMAL PARTS ARE CHARRED, WHICH CREATES SPARKS DURING THEIR USE". ACCORDING TO FURTHER RECEIVED INFORMATION THERE WAS A SURGICAL DELAY OF LESS THAN 15 MINUTES, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO AFFECT ON A PATIENT, USER OR THIRD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870984 ↗MalfunctionApr 27, 2020Product Quality Problem; Product Quality Problem
ALLEGEDLY, PER THE FACILITY THE INSULATION AT THE TIP OF THE COAGULATING AND DISSECTING L-HOOK ELECTRODE DID NOT INSULATE THE CAUTERY TIP AND COULD HAVE BURNED THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10002991 ↗MalfunctionApr 27, 2020Product Quality Problem; Product Quality Problem
ALLEGEDLY, PER THE FACILITY THE INSULATION AT THE TIP OF THE COAGULATING AND DISSECTING L-HOOK ELECTRODE DID NOT INSULATE THE CAUTERY TIP AND COULD HAVE BURNED THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10002839 ↗MalfunctionApr 27, 2020Product Quality Problem; Product Quality Problem
ALLEGEDLY, PER THE FACILITY THE INSULATION AT THE TIP OF THE COAGULATING AND DISSECTING L-HOOK ELECTRODE DID NOT INSULATE THE CAUTERY TIP AND COULD HAVE BURNED THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10002816 ↗MalfunctionApr 17, 2020Product Quality Problem; Product Quality Problem
ALLEGEDLY, PER THE FACILITY THE INSULATION AT THE TIP OF THE COAGULATING AND DISSECTING L-HOOK ELECTRODE DID NOT INSULATE THE CAUTERY TIP AND COULD HAVE BURNED THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9971903 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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