n.a. 26040EBRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04048551091784), received between Aug 13, 2021 and Aug 11, 2026 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unintended Electrical Shock” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Insufficient Device Problem Information

  It was reported that during the procedure, the patient complained of shortness of breath, so we switched from local to general anesthesia. An ultrasound examination confirmed that the patient had developed an air embolism. We then used a stent to remove 20 cc of air from the inferior vena cava. No permanent impairment or long-term adverse outcome was reported.Cross reference MDR:9610617-2026-01919.

  Patient problems: Air Embolism

  MAUDE report 50212550 ↗
• InjuryAug 11, 2026Insufficient Device Problem Information

  It was reported that during the procedure, the patient complained of shortness of breath, so we switched from local to general anesthesia. An ultrasound examination confirmed that the patient had developed an air embolism. We then used a stent to remove 20 cc of air from the inferior vena cava. No permanent impairment or long-term adverse outcome was reported. Cross reference MDR: 9610617-2026-01919.

  Patient problems: Air Embolism

  MAUDE report 50212546 ↗
• InjuryAug 11, 2026Unintended Electrical Shock

  It was reported that on (b)(6) 2026, following normal surgical procedures, hysteroscopic endometrial lesion resection and hysteroscopic diagnostic curettage were planned for the patient. During the use of high-frequency surgical equipment, the working handpiece suddenly malfunctioned and burned the bipolar electrode cable, causing transient electric shock to the patient. The surgical equipment was suspended immediately. After replacing the spare working handpiece and electrode cable and confirming no abnormalities, the operation resumed.Cross Reference MDR 9610617-2026-01911.Cross Reference MDR 9610617-2026-01912.

  Patient problems: Electric Shock

  MAUDE report 50201369 ↗
• InjuryAug 11, 2026Unintended Electrical Shock

  It was reported that on (b)(6) 2026, following normal surgical procedures, hysteroscopic endometrial lesion resection and hysteroscopic diagnostic curettage were planned for the patient. During the use of high-frequency surgical equipment, the working handpiece suddenly malfunctioned and burned the bipolar electrode cable, causing transient electric shock to the patient. The surgical equipment was suspended immediately. After replacing the spare working handpiece and electrode cable and confirming no abnormalities, the operation resumed. Cross Reference MDR 9610617-2026-01911. Cross Reference MDR 9610617-2026-01912.

  Patient problems: Electric Shock

  MAUDE report 50201367 ↗
• InjuryAug 7, 2026Unintended Electrical Shock

  It was reported that "On (b)(6) 2026, following normal surgical procedures, hysteroscopic endometrial lesion resection and hysteroscopic diagnostic curettage were planned for the patient. During the use of high-frequency surgical equipment, the working handpiece suddenly malfunctioned and burned the bipolar electrode cable, causing transient electric shock to the patient. The surgical equipment was suspended immediately. After replacing the spare working handpiece and electrode cable and confirming no abnormalities, the operation resumed."Cross reference MDR 9610617-2026-1892,Cross reference MDR 9610617-2026-1893.

  Patient problems: Electric Shock

  MAUDE report 50180962 ↗
• InjuryAug 3, 2026Insufficient Device Problem Information

  Patient problems: Electric Shock

  MAUDE report 50122175 ↗
• InjuryAug 3, 2026Insufficient Device Problem Information

  It was reported that on (b)(6) 2026, according to the standard surgical procedure, the patient was scheduled to undergo hysteroscopic endometrial lesion resection + hysteroscopic cervical lesion resection + fractional diagnostic curettage + cervical biopsy. During the operation, while using the high-frequency electrosurgical device, the working handpiece suddenly burned through the bipolar electrode cable, causing the patient to experience a brief electric shock. The use of the device was immediately discontinued, and a backup working handpiece and electrode cable were replaced. After confirming no issues, the surgery continued. New additional information was received on July 24, 2026. Based on the new information there are 3 additional potentially causal KARL STORZ products involved in the event and additional reported error description: "The sealing ring leaks, and water flows through the gap to the electrode cable during the procedure." Cross reference MDR: 9610617-2026-01599, 9610617-2026-01797. 9610617-2026-01798.

  Patient problems: Electric Shock

  MAUDE report 50122169 ↗
• MalfunctionApr 15, 2026Corroded; Detachment of Device or Device Component

  IT WAS REPORTED THAT "AT 17:55 ON (B)(6) 2026, DURING INSTRUMENT ASSEMBLY, SURGEON WANG YU GENTLY PUSHED THE BIPOLAR HANDLE, CAUSING THE FINGER RING TO DETACH. COMPLETE RUSTING WAS OBSERVED AT THE INTERFACE, WITH SCREWS ALSO RUSTED.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24881439 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT THE WORKING ELEMENT WAS FOUND BROKEN DURING PREOPERATIVE INSPECTION. THE PATIENT HAD ALREADY BEEN ANESTHETIZED AT THAT TIME. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING IT WITH A NEW ONE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818979 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT "THE WORKING ELEMENT WAS FOUND BROKEN DURING PREOPERATIVE INSPECTION. THE PATIENT HAD ALREADY BEEN ANESTHETIZED AT THAT TIME. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING IT WITH A NEW ONE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817787 ↗
• InjuryDec 2, 2025Sparking; Sparking

  ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT WAS ADMITTED DUE TO "10 DAYS OF IRREGULAR VAGINAL BLEEDING." ADMISSION DIAGNOSIS: ABNORMAL UTERINE BLEEDING, INTRAUTERINE DEVICE IN SITU. ON (B)(6) 2025, A HYSTEROSCOPIC PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, AN ENDOMETRIAL POLYP WAS IDENTIFIED, AND A HYSTEROSCOPIC ENDOMETRIAL POLYPECTOMY WITH IUD REMOVAL WAS PLANNED. THE SURGERY WAS PERFORMED USING A STORZ 2 SYSTEM. DURING THE OPERATION, A SHORT CIRCUIT AND EXPLOSION OCCURRED AT THE CONNECTION POINT BETWEEN THE RESECTOSCOPE LOOP CABLE AND THE SHEATH HUB, ACCOMPANIED BY VISIBLE SPARKS. THIS RESULTED IN A BURN INJURY TO THE OPERATOR'S FINGER, CHARACTERIZED BY LOCALIZED REDNESS AND SIGNIFICANT PAIN.

  Patient problems: Burn(s)

  MAUDE report 23700744 ↗
• InjuryDec 2, 2025Sparking; Sparking

  ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT WAS ADMITTED DUE TO "10 DAYS OF IRREGULAR VAGINAL BLEEDING." ADMISSION DIAGNOSIS: ABNORMAL UTERINE BLEEDING, INTRAUTERINE DEVICE IN SITU. ON (B)(6) 2025, A HYSTEROSCOPIC PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, AN ENDOMETRIAL POLYP WAS IDENTIFIED, AND A HYSTEROSCOPIC ENDOMETRIAL POLYPECTOMY WITH IUD REMOVAL WAS PLANNED. THE SURGERY WAS PERFORMED USING A STORZ 2 SYSTEM. DURING THE OPERATION, A SHORT CIRCUIT AND EXPLOSION OCCURRED AT THE CONNECTION POINT BETWEEN THE RESECTOSCOPE LOOP CABLE AND THE SHEATH HUB, ACCOMPANIED BY VISIBLE SPARKS. THIS RESULTED IN A BURN INJURY TO THE OPERATOR'S FINGER, CHARACTERIZED BY LOCALIZED REDNESS AND SIGNIFICANT PAIN.

  Patient problems: Burn(s)

  MAUDE report 23700743 ↗
• InjuryNov 26, 2025Unintended Electrical Shock; Unintended Electrical Shock

  ACCORDING TO THE INFORMATION RECEIVED, DR (B)(6) WAS PERFORMING A CYSTOSCOPY TURP. HE WAS RE-INSERTING THE WORKING ELEMENT INTO THE SHEATH, AND IT SHOCKED HIS HAND. HE WAS NOT INJURED NOR WAS THE PATIENT. IT DELAYED THE CASE FOR 10 MINUTES WHILE THEY SWITCHED OUT THE EQUIPMENT. DOCTOR SWITCHED TO OTHER DEVICE AND COMPLETED THE PROCEDURE WITHOUT INJURY TO PATIENT. CROSS REFERENCE MDR: (B)(4).

  Patient problems: Electric Shock

  MAUDE report 23663011 ↗
• InjuryNov 26, 2025Unintended Electrical Shock; Unintended Electrical Shock

  ACCORDING TO THE INFORMATION RECEIVED, DR (B)(6) WAS PERFORMING A CYSTOSCOPY TURP. HE WAS RE-INSERTING THE WORKING ELEMENT INTO THE SHEATH, AND IT SHOCKED HIS HAND. HE WAS NOT INJURED NOR WAS THE PATIENT. IT DELAYED THE CASE FOR 10 MINUTES WHILE THEY SWITCHED OUT THE EQUIPMENT. DOCTOR SWITCHED TO OTHER DEVICE AND COMPLETED THE PROCEDURE WITHOUT INJURY TO PATIENT. CROSS REFERENCE MDR: 9610617-2025-02197.

  Patient problems: Electric Shock

  MAUDE report 23663010 ↗
• InjuryJan 31, 2025Device Handling Problem; Unintended Electrical Shock; Device Handling Problem; Unintended Electrical Shock

  IT WAS REPORTED THAT LEAKAGE OCCURRED IN THE USE OF ELECTRIC ENDOSCOPIC INSTRUMENTS IN THE OPERATION BY USER, AND SHOCKED THE PATIENT, BUT ONLY CONVULSED DURING THE OPERATION, CAUSING NO SERIOUS INJURY, AND THERE WAS NO INTERVENTION TREATMENT IN THE LATER STAGE. IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO FURTHER IMPACT OR CONSEQUENCES. HOWEVER, DUE TO THE REPORTED SHOCK AND CONVULSION OF THE PATIENT THIS CASE IS DEEMED REPORTABLE FOR PRECAUTIONARY REASONS.

  Patient problems: Convulsion/Seizure; Electric Shock

  MAUDE report 21287055 ↗
• InjuryJan 31, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT LEAKAGE OCCURRED IN THE USE OF ELECTRIC ENDOSCOPIC INSTRUMENTS IN THE OPERATION BY USER, AND SHOCKED THE PATIENT, BUT ONLY CONVULSED DURING THE OPERATION, CAUSING NO SERIOUS INJURY, AND THERE WAS NO INTERVENTION TREATMENT IN THE LATER STAGE. IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO FURTHER IMPACT OR CONSEQUENCES. HOWEVER, DUE TO THE REPORTED SHOCK AND CONVULSION OF THE PATIENT THIS CASE IS DEEMED REPORTABLE FOR PRECAUTIONARY REASONS.

  Patient problems: Convulsion/Seizure; Electric Shock

  MAUDE report 21287054 ↗
• InjuryJan 31, 2025Leak/Splash; Unintended Electrical Shock; Leak/Splash; Unintended Electrical Shock

  IT WAS REPORTED THAT LEAKAGE OCCURRED IN THE USE OF ELECTRIC ENDOSCOPIC INSTRUMENTS IN THE OPERATION BY USER, AND SHOCKED THE PATIENT, BUT ONLY CONVULSED DURING THE OPERATION, CAUSING NO SERIOUS INJURY, AND THERE WAS NO INTERVENTION TREATMENT IN THE LATER STAGE. IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO FURTHER IMPACT OR CONSEQUENCES. HOWEVER, DUE TO THE REPORTED SHOCK AND CONVULSION OF THE PATIENT THIS CASE IS DEEMED REPORTABLE FOR PRECAUTIONARY REASONS.

  Patient problems: Convulsion/Seizure; Electric Shock

  MAUDE report 21287053 ↗
• InjuryJan 31, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT LEAKAGE OCCURRED IN THE USE OF ELECTRIC ENDOSCOPIC INSTRUMENTS IN THE OPERATION BY USER, AND SHOCKED THE PATIENT, BUT ONLY CONVULSED DURING THE OPERATION, CAUSING NO SERIOUS INJURY, AND THERE WAS NO INTERVENTION TREATMENT IN THE LATER STAGE. IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO FURTHER IMPACT OR CONSEQUENCES. HOWEVER, DUE TO THE REPORTED SHOCK AND CONVULSION OF THE PATIENT THIS CASE IS DEEMED REPORTABLE FOR PRECAUTIONARY REASONS.

  Patient problems: Convulsion/Seizure; Electric Shock

  MAUDE report 21287052 ↗
• InjuryAug 13, 2021Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Gas/Air Leak; Adverse Event Without Identified Device or Use Problem

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): IT WAS REPORTED THAT DURING PATIENT TREATMENT A LEAKAGE PROVOKED AN AIR EMBOLISM. NO FURTHER INFORMATION REGARDING THE STATE OF HEALTH IS AVAILABLE.

  Patient problems: Air Embolism

  MAUDE report 12321069 ↗