n.a. UH801Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 04048551388778), received between Jun 3, 2022 and Sep 24, 2026 — classified as 36 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Sparking” (24 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 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Overheating of Device

  It was reported that while being used, it works but it burns. Burn marks can be observed at connection point of working element and lead.Cross Reference MDR 9610617-2026-02230.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883748 ↗
• InjurySep 17, 2026Sparking

  The following was reported: The incident involved an unexpected sparking event associated with the bipolar HF cable during an operative hysteroscopy procedure. The event resulted in minor apparent thermal effects to staff protective clothing and localized redness to the attending physician, while no patient injury was identified. Degree of burn is unknown.

  Patient problems: Burn(s)

  MAUDE report 50803461 ↗
• 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 9610617-2026-01913.

  Patient problems: Electric Shock

  MAUDE report 50201364 ↗
• InjuryAug 11, 2026Unintended Electrical Shock

  It was reported that on May 22, 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 9610617-2026-01913.

  Patient problems: Electric Shock

  MAUDE report 50201361 ↗
• 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 9610617-2026-1891.Cross reference MDR 9610617-2026-1893.

  Patient problems: Electric Shock

  MAUDE report 50180965 ↗
• 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 9610617-2026-1891,Cross reference MDR 9610617-2026-1893.

  Patient problems: Electric Shock

  MAUDE report 50180964 ↗
• InjuryAug 3, 2026Insufficient Device Problem Information

  Patient problems: Electric Shock

  MAUDE report 50122174 ↗
• 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. 9610617-2026-01799.

  Patient problems: Electric Shock

  MAUDE report 50122166 ↗
• MalfunctionJul 30, 2026Sparking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50089548 ↗
• InjuryMay 27, 2026Electrical /Electronic Property Problem

  THE FOLLOWING WAS REPORTED: THE BIPOLAR HIGH FREQUENCY CORD UH801 WAS FOUND TO BE BURNT/SCORCHED THE PATIENT REPORTEDLY EXPERIENCED A MILD ELECTRIC SHOCK. DUE TO THE REPORTED ELECTRIC SHOCK, THIS CASE IS DEEMED REPORTABLE.

  Patient problems: Electric Shock

  MAUDE report 25307065 ↗
• InjuryMay 27, 2026Electrical /Electronic Property Problem

  THE FOLLOWING WAS REPORTED: THE BIPOLAR HIGH FREQUENCY CORD UH801 WAS FOUND TO BE BURNT/SCORCHED THE PATIENT REPORTEDLY EXPERIENCED A MILD ELECTRIC SHOCK. DUE TO THE REPORTED ELECTRIC SHOCK, THIS CASE IS DEEMED REPORTABLE.

  Patient problems: Electric Shock

  MAUDE report 25307042 ↗
• MalfunctionMay 8, 2026Sparking

  THE EVENT OCCURRED IN BRAZIL. IT WAS REPORTED THAT DURING THE PROSTATE RESECTION SURGERY [[?]] THE DOCTOR REPORTED THAT THERE WAS A SPARK COMING FROM THE HANDPIECE, BIPOLAR WORKING ELEMENT. THE HANDPIECE WAS REPLACED IMMEDIATELY, AND THE SURGEON CONTINUED THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-1059.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130631 ↗
• InjuryApr 29, 2026Electrical Shorting

  THE FOLLOWING WAS REPORTED: AT 9:30 A.M. ON (B)(6) 2026, DURING SURGICAL TISSUE RESECTION ON A PATIENT, THE ELECTROSURGICAL CUTTING WIRE SUDDENLY SHORT-CIRCUITED AND BURNED OUT, RESULTING IN A BURN ON THE PATIENT'S SKIN SURFACE. ACCORDING TO THE PROVIDED INFORMATION, A TREATMENT OF THE BURN WAS REQUIRED. DUE TO THE REPORTED BURN ON THE PATENT'S SKIN, THIS CASE IS DEEMED REPORTABLE.

  Patient problems: Burn(s)

  MAUDE report 25036843 ↗
• MalfunctionApr 2, 2026Sparking

  IT WAS REPORTED THAT THERE WAS AN ELECTRICAL SPARK AND ASHES WERE SEEN AFTER THE SPARK. IT IS NOT SURE IF THE ELECTRICAL SPARK RELATED TO THE CORD OR THE WORKING ELEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769658 ↗
• MalfunctionMar 30, 2026Smoking

  IT WAS REPORTED THAT THE LEAD STARTED TO SMOKE SO THEY STOPPED USING AND REPORTED TO SSD. PATIENT WAS NOT AFFECTED BY THIS AS IT WAS NOTICED BEFORE PROCEDURE. THEATRE STAFF OPENED ANOTHER TRAY AND USED THIS INSTEAD. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708731 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem; Unintended Electrical Shock

  THE FOLLOWING WAS REPORTED:DURING HYSTEROSCOPIC TRANSCERVICAL RESECTION OF THE ENDOMETRIUM, THE PATIENT DEVELOPED CONVULSIONS WHEN THE FOOT PEDAL WAS PRESSED TO ACTIVATE RESECTION. AFTER CONFIRMING THE ANESTHESIA DEPTH, THE PATIENT STILL RESPONDED WHEN THE FOOT PEDAL WAS PRESSED AGAIN, WITH REFLEX MUSCLE CONTRACTION TRIGGERED BY THE PEDAL. THE SURGERY WAS SUSPENDED, AND ANOTHER SET OF RESECTION EQUIPMENT, INSTRUMENTS, ENDOSCOPE AND ELECTRODE WERE REPLACED. A CURRENT LEAKAGE IS SUSPECTED, AND THE PATIENT SUFFERED A MILD ELECTRIC SHOCK. NO SKIN BURNS (SUCH AS REDNESS, BLISTERS, ESCHAR, ETC.) WERE REPORTED POSTOPERATIVELY, BUT MUSCLE PAIN MASKED BY THE POSTOPERATIVE ANALGESIA PUMP CANNOT BE EXCLUDED. DUE TO THE REPORTED ELECTRIC SHOCK, THIS CASE IS DEEMED REPORTABLE.

  Patient problems: Electric Shock

  MAUDE report 24613783 ↗
• InjuryMar 16, 2026Unintended Electrical Shock

  THE FOLLOWING WAS REPORTED:DURING HYSTEROSCOPIC TRANSCERVICAL RESECTION OF THE ENDOMETRIUM, THE PATIENT DEVELOPED CONVULSIONS WHEN THE FOOT PEDAL WAS PRESSED TO ACTIVATE RESECTION. AFTER CONFIRMING THE ANESTHESIA DEPTH, THE PATIENT STILL RESPONDED WHEN THE FOOT PEDAL WAS PRESSED AGAIN, WITH REFLEX MUSCLE CONTRACTION TRIGGERED BY THE PEDAL. THE SURGERY WAS SUSPENDED, AND ANOTHER SET OF RESECTION EQUIPMENT, INSTRUMENTS, ENDOSCOPE AND ELECTRODE WERE REPLACED. A CURRENT LEAKAGE IS SUSPECTED, AND THE PATIENT SUFFERED A MILD ELECTRIC SHOCK. NO SKIN BURNS (SUCH AS REDNESS, BLISTERS, ESCHAR, ETC.) WERE REPORTED POSTOPERATIVELY, BUT MUSCLE PAIN MASKED BY THE POSTOPERATIVE ANALGESIA PUMP CANNOT BE EXCLUDED. DUE TO THE REPORTED ELECTRIC SHOCK, THIS CASE IS DEEMED REPORTABLE.

  Patient problems: Electric Shock

  MAUDE report 24613781 ↗
• InjuryFeb 16, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE SURGEON EVEN BURNED THE UPPER PART OF HIS INDEX FINGER DURING THE USE OF THE RESECTOSCOPE. DUE TO THIS BURN THE CASE IS DEEMED REPORTABLE.

  Patient problems: Burn(s)

  MAUDE report 24354528 ↗
• InjuryFeb 16, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE SURGEON EVEN BURNED THE UPPER PART OF HIS INDEX FINGER DURING THE USE OF THE RESECTOSCOPE. DUE TO THIS BURN THE CASE IS DEEMED REPORTABLE.

  Patient problems: Burn(s)

  MAUDE report 24354524 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CABLES KEEP MELTING ONE AFTER ANOTHER AFTER JUST A SINGLE USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308836 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CABLES KEEP MELTING ONE AFTER ANOTHER AFTER JUST A SINGLE USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308814 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CABLES KEEP MELTING ONE AFTER ANOTHER AFTER JUST A SINGLE USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308813 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CABLES KEEP MELTING ONE AFTER ANOTHER AFTER JUST A SINGLE USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308812 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CABLES KEEP MELTING ONE AFTER ANOTHER AFTER JUST A SINGLE USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308811 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CABLES KEEP MELTING ONE AFTER ANOTHER AFTER JUST A SINGLE USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308807 ↗