BLUEENDO 02-33117Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04251303811435), received between Jun 27, 2023 and Dec 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Shut Off” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2023Failure to Shut Off; Failure to Shut Off

  THE PROBLEM WAS REPORTED TO US VIA CUSTOMER COMPLAINT (B)(4) ON (B)(6) 2023: WHEN USING THE MORCELLATOR, THE CUTTING MODULE CONTINUED TO ROTATE EVEN THOUGH THE ACTIVATION SWITCH OF THE HANDLE MODULE WAS RELEASED BY THE USER. THE UB-20230501_MORCELLATOR_SCHALTER INVESTIGATION REPORT WAS PREPARED TO ANALYZE THE CAUSE.THE CAUSE OF THE ERROR PATTERN WAS FOUND TO BE A FAULTY SWITCH FUNCTION, I.E. THE CONTACT DISTANCES OF THE SWITCH MAY BE TOO SMALL. THE SEAT OF THE FIXING SCREW OF THE ACTIVATION SWITCH IN THE GRIP MODULE WAS TESTED WITH AN UNSUITABLE TESTING DEVICE. AS A RESULT, PRODUCTS WITH TOO SMALL A SWITCH CONTACT DISTANCE (CONTACT SCREW TO SPRING PLATE) HAVE COME INTO CIRCULATION. WITH THESE PRODUCTS, IT IS THEREFORE POSSIBLE THAT THE GRIP MODULE TRANSMITS AN "ON" SIGNAL TO THE CONTROL UNIT EVEN AFTER THE ACTIVATION SWITCH HAS BEEN RELEASED AND THAT THE CUTTING MODULE CONTINUES TO ROTATE EVEN AFTER THE ACTIVATION SWITCH HAS BEEN RELEASED.REASON FOR FSCA: URGENT SAFETY INFORMATION IS BEING ISSUED TO REDUCE THE RISK OF THE OCCURRENCE OF A SIGNIFICANT DELAY IN THE MEDICAL PROCEDURE IF A USER HAS TO MAKE AN UNPLANNED CHANGE FROM HAND TO FOOT CONTROL DURING A PROCEDURE DUE TO THE SUDDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18265377 ↗
• MalfunctionJun 27, 2023Failure to Shut Off; Failure to Shut Off

  THE PROBLEM WAS REPORTED TO US VIA CUSTOMER COMPLAINT (B)(4) ON (B)(6).2023: WHEN USING THE MORCELLATOR, THE CUTTING MODULE CONTINUED TO ROTATE EVEN THOUGH THE ACTIVATION SWITCH OF THE HANDLE MODULE WAS RELEASED BY THE USER. THE UB-20230501_MORCELLATOR_SCHALTER INVESTIGATION REPORT WAS PREPARED TO ANALYZE THE CAUSE.THE CAUSE OF THE ERROR PATTERN WAS FOUND TO BE A FAULTY SWITCH FUNCTION, I.E. THE CONTACT DISTANCES OF THE SWITCH MAY BE TOO SMALL. THE SEAT OF THE FIXING SCREW OF THE ACTIVATION SWITCH IN THE GRIP MODULE WAS TESTED WITH AN UNSUITABLE TESTING DEVICE. AS A RESULT, PRODUCTS WITH TOO SMALL A SWITCH CONTACT DISTANCE (CONTACT SCREW TO SPRING PLATE) HAVE COME INTO CIRCULATION. WITH THESE PRODUCTS, IT IS THEREFORE POSSIBLE THAT THE GRIP MODULE TRANSMITS AN "ON" SIGNAL TO THE CONTROL UNIT EVEN AFTER THE ACTIVATION SWITCH HAS BEEN RELEASED AND THAT THE CUTTING MODULE CONTINUES TO ROTATE EVEN AFTER THE ACTIVATION SWITCH HAS BEEN RELEASED.REASON FOR FSCA: URGENT SAFETY INFORMATION IS BEING ISSUED TO REDUCE THE RISK OF THE OCCURRENCE OF A SIGNIFICANT DELAY IN THE MEDICAL PROCEDURE IF A USER HAS TO MAKE AN UNPLANNED CHANGE FROM HAND TO FOOT CONTROL DURING A PROCEDURE DUE TO THE SUDDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210931 ↗