n.a. 27040DBRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04048551075500), received between Sep 13, 2023 and May 8, 2026 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT TWO INSTRUMENT HANDLES, REF. 27040DB: THE ONE USED WITH SNRK22: DURING USE, THE RESECTION LOOP MOVES OUT OF THE OPTICAL FIELD OF VIEW, EVEN THOUGH THE ASSEMBLY IS CORRECT. THE ONE USED WITH SN (B)(6): THE BIPOLAR RESECTION CABLE BURNED AT THE POINT OF INSERTION INTO THE HANDLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129087 ↗
• MalfunctionMay 8, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT TWO INSTRUMENT HANDLES, REF. (B)(4): THE ONE USED WITH SNRK22: DURING USE, THE RESECTION LOOP MOVES OUT OF THE OPTICAL FIELD OF VIEW, EVEN THOUGH THE ASSEMBLY IS CORRECT. THE ONE USED WITH SN OM03: THE BIPOLAR RESECTION CABLE BURNED AT THE POINT OF INSERTION INTO THE HANDLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25127017 ↗
• MalfunctionMar 13, 2026Arcing

  IT WAS REPORTED THAT "DURING SURGERY SPARKS OF FIRE CAME FROM THE WORKING ELEMENT AND THE ERBE CABLE 20196-118". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596661 ↗
• MalfunctionDec 30, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT "MALFUNCTION DETECTED IN THE ANESTHESIA DEVICE'S HEART RATE MONITOR. THE CABLE AND INSULATION ON THE WORKING ELEMENT ARE BURNT OUT, POSSIBLY DUE TO A SHORT CIRCUIT". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928248 ↗
• InjuryAug 25, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE ELECTRODE WAS NOT FIXED TO THE WORKING ELEMENT AND CONTINUED TO SEPARATE. AS A RESULT OF INSPECTING BOTH PRODUCTS, IT WAS DETERMINED THAT THE ELECTRODE WAS DEFECTIVE. THE SYMPTOM OF THE DEFECT WAS THAT THERE SHOULD HAVE BEEN A FIXING GROOVE, BUT THE GROOVE WAS NOT PROPERLY CREATED. THERE WAS NO DIRECT IMPACT ON THE PATIENT, BUT SINCE THE SURGERY WAS EXTENDED BY ABOUT 40 MINUTES THE EVENT IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884801 ↗
• InjuryMay 25, 2025Misconnection; Device Handling Problem; Misconnection; Device Handling Problem

  IT WAS REPORTED THAT THE ELECTRODE WAS NOT FIXED TO THE WORKING ELEMENT AND CONTINUED TO SEPARATE. AS A RESULT OF INSPECTING BOTH PRODUCTS, IT WAS DETERMINED THAT THE ELECTRODE WAS DEFECTIVE. THE SYMPTOM OF THE DEFECT WAS THAT THERE SHOULD HAVE BEEN A FIXING GROOVE, BUT THE GROOVE WAS NOT PROPERLY CREATED. THERE WAS NO DIRECT IMPACT ON THE PATIENT, BUT SINCE THE SURGERY WAS EXTENDED BY ABOUT 40 MINUTES THE EVENT IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082512 ↗
• InjuryMay 2, 2025Misconnection; Device Dislodged or Dislocated; Misconnection; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ELECTRODE WAS NOT FIXED TO THE WORKING ELEMENT AND CONTINUED TO SEPARATE. AS A RESULT OF INSPECTING BOTH PRODUCTS, IT WAS DETERMINED THAT THE ELECTRODE WAS DEFECTIVE. THE SYMPTOM OF THE DEFECT WAS THAT THERE SHOULD HAVE BEEN A FIXING GROOVE, BUT THE GROOVE WAS NOT PROPERLY CREATED. THERE WAS NO DIRECT IMPACT ON THE PATIENT, BUT SINCE THE SURGERY WAS EXTENDED BY ABOUT 40 MINUTES THE EVENT IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952240 ↗
• InjuryAug 15, 2024Smoking; Temperature Problem; Smoking; Temperature Problem

  IT WAS REPORTED THAT A PROBLEM REGARDING UROLOGY BIPOLAR WORKING ELEMENT 27040DB BURNING AND SMOKING WHILE IN USE AFTER THE CASE THE SURGEON HAS SAID HE HAS ALSO GOT SORE FINGER, IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT. HOWEVER, DUE TO THE MENTIONED SORE FINGER OF THE SURGEON, THIS CASE IS DEEMED REPORTABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19995219 ↗
• InjuryJul 25, 2024Energy Output Problem; Overheating of Device; Energy Output Problem; Overheating of Device

  ACCORDING TO THE INFORMATION RECEIVED, DURING A BIPOLAR PHOTOVAPORIZATION OF THE PROSTATE: BLACK SMOKE AND FLAME ON THE CONNECTION OF THE BIPOLAR CABLE AND THE RESECTOSCOPE OCCURRED. NO NEGATIVE EFFECTS ON THE PATIENT WERE REPORTED. BUT THE SURGEON SUFFERED BURNS.

  Patient problems: Burn(s)

  MAUDE report 19829376 ↗
• InjuryJul 25, 2024Overheating of Device; Overheating of Device

  ACCORDING TO THE INFORMATION RECEIVED, DURING A BIPOLAR PHOTOVAPORIZATION OF THE PROSTATE: BLACK SMOKE AND FLAME ON THE CONNECTION OF THE BIPOLAR CABLE AND THE RESECTOSCOPE OCCURRED. NO NEGATIVE EFFECTS ON THE PATIENT WERE REPORTED. BUT THE SURGEON SUFFERED BURNS.

  Patient problems: Burn(s)

  MAUDE report 19829323 ↗
• MalfunctionMay 23, 2024Sparking; Flare or Flash; Sparking; Flare or Flash

  IT WAS REPORTED THAT THE WORKING ELEMENT AND LEAD SPARKED DURING THE CASE. IT HAS BEEN CONFIRMED THAT THE ELECTRODE WAS INSIDE THE PATIENT WHEN THE INCIDENT OCCURRED, THEY STOPPED THE PROCEDURE STRAIGHTWAY. NO HARM TO THE PATIENT OR THE SURGEON WAS NOTED. ANOTHER SYSTEM WAS USED TO COMPLETE THE PROCEDURE RIGHT AFTER THE INCIDENT. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19384671 ↗
• MalfunctionApr 11, 2024Fire; Smoking; Fire; Smoking

  IT WAS REPORTED THAT SMOKE HAD COME OUT DURING THE INTERVENTION AND THE DEVICE GOT FIRE. THERE WAS A SURGICAL PROLONGATION "DELAY" BECAUSE THEY HAD TO CHANGE THE RESECTION AREA PER OPERATION." PROCEDURE WAS COMPLETED SUCCESSFULLY, NO MEDICAL/ SURGICAL/ DIAGNOSTICAL INTERVENTION WAS REQUIRED. NO ADVERSE CONSEQUENCES REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088626 ↗
• InjurySep 13, 2023Energy Output Problem; Insufficient Device Problem Information; Energy Output Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A WORKING ELEMENT. THERE IS NO FAILURE DESCRIPTION AVAILABLE. ACCORDING TO THE INFORMATION RECEIVED THERE WAS AN ADDITIONAL MEDICAL INTERVENTION NECESSARY DUE TO THE INCIDENT REPORTED AND A POOR HAEMOSTASIS OCCURRED. DUE TO LIMITED INFORMATION AND THE INFORMATION MENTIONED ABOVE THIS CASE WAS RATED DEEMED REPORTABLE. ADDITIONAL INFORMATION WAS ALREADY REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED UNSOLICITED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17738497 ↗
• InjurySep 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A WORKING ELEMENT. THERE IS NO FAILURE DESCRIPTION AVAILABLE. ACCORDING TO THE INFORMATION RECEIVED THERE WAS AN ADDITIONAL MEDICAL INTERVENTION NECESSARY DUE TO THE INCIDENT REPORTED AND A POOR HAEMOSTASIS OCCURRED . DUE TO LIMITED INFORMATION AND THE INFORMATION MENTIONED ABOVE THIS CASE WAS RATED DEEMED REPORTABLE. ADDITIONAL INFORMATION WAS ALREADY REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED UNSOLICITED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17738496 ↗