n.a. 27050DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551077474), received between Apr 29, 2021 and Aug 18, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Excessive Heating

  The following was reported: "The hospital unfortunately had an incident in theatre where a patient sustained a thermal injury from a Resection scope. The team and surgeon report that the burn looked like it came from around the area where the cable plugs in to the scope. On closer inspection they noticed a small area where the metal has blackened which may indicate a leak from the loop filament rather than the instrument."

  Patient problems: Burn(s)

  MAUDE report 50310110 ↗
• InjuryFeb 27, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SURGEON BEGAN THE COAGULATION PROCESS. THE NEUTRAL ELECTRODE SHOWED A GREEN LIGHT. AFTER JUST ONE OR TWO ATTEMPTS, THE ERBE VIO 300 DEVICE REPORTED AN ERROR/MALFUNCTION AT THE NEUTRAL ELECTRODE, EVEN THOUGH THE ELECTRODE CONTINUED TO GLOW GREEN. WHEN THE SURGEON RESTARTED THE COAGULATION PROCESS, THERE WAS A VIOLENT BACKLASH' IN WHICH THE IRRIGATION WATER SPRAYED OUT OF THE BLADDER AND THE SURGEON REPORTED RECEIVING AN ELECTRIC SHOCK. THERE WAS A BURNING SMELL IN THE OPERATING THEATRE. THE SURGEON'S GLOVE WAS TORN AND THERE WAS A CLEAR BURN MARK ON HER THUMB. SHE COMPLAINED OF FEELING UNWELL AND DIZZY AND LEFT THE OPERATING THEATRE. THE OPERATION WAS INTERRUPTED AND THE ERBE VIO 300 DEVICE, THE RESECTOSCOPE AND THE POWER CABLE WERE IMMEDIATELY REPLACED WITH NEW' DEVICES." ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THE PROCEDURE WAS COMPLETED BY ANOTHER SURGEON WITHOUT ANY FURTHER PROBLEMS. THE SURGEON WHO RECEIVED THE ELECTRIC SHOCK REPORTED THAT SHE WAS "MONITORED FOR SEVERAL HOURS WITH TWO ECG CHECKS AND TWO HEART ENZYME CHECKS WITHOUT DYNAMICS. APART FROM CLEAR SECRETION FROM THE WOUND ON THE RIGHT THUMB, NO SIGNS OF INFLAMMATION OCCURRED IN THE FURTH

  Patient problems: Burn(s)

  MAUDE report 24471445 ↗
• InjuryApr 29, 2021Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  AS PER A MANUFACTURER INCIDENT FINAL REPORT WE RECEIVED FROM THE FACTORY IN GERMANY: THE SURGERY WAS EXTENDED INTO A LAPARATOMY TO REPAIR THE BLADDER.

  Patient problems: Insufficient Information; Internal Organ Perforation

  MAUDE report 11744792 ↗