UNIDRIVE 20701020-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04048551278802), received between Dec 6, 2024 and Aug 20, 2026 — classified as 6 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Output Problem; Appropriate Device Problem Term/Code Not Available

  The following was reported: The patient underwent hysteroscopy. Equipment failure occurred during the procedure, resulting in inability to complete the surgery. The equipment has been taken out of service and returned for repair. No harm was caused to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50352083 ↗
• InjuryAug 20, 2026Output Problem

  The following was reported: The patient underwent hysteroscopy. Equipment failure occurred during the procedure, resulting in inability to complete the surgery. The equipment has been taken out of service and returned for repair. No harm was caused to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50352082 ↗
• InjuryApr 3, 2026Power Problem

  IT WAS REPORTED THAT "I ALSO WANTED TO GET IN TOUCH AGAIN REGARDING THE NEEDLE HOLDER, WHICH, DUE TO A MATERIAL DEFECT, RESULTED IN A FURTHER OPERATION ON A CHILD" DUE TO FURTHER OPERATION ON A CHILD REQUIRED, THIS CASE IS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783280 ↗
• InjuryApr 3, 2026Power Problem

  IT WAS REPORTED THAT "I ALSO WANTED TO GET IN TOUCH AGAIN REGARDING THE NEEDLE HOLDER, WHICH, DUE TO A MATERIAL DEFECT, RESULTED IN A FURTHER OPERATION ON A CHILD" DUE TO FURTHER OPERATION ON A CHILD REQUIRED, THIS CASE IS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783278 ↗
• MalfunctionMar 11, 2026Energy Output Problem

  THE FOLLOWING WAS REPORTED: "THE MORCELLATOR SHOWS AN ERROR (ERROR 11). IT IS IMPOSSIBLE TO MAKE IT WORK" NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573382 ↗
• InjuryDec 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE "FOOT PEDAL AND MORCELLATOR UNABLE TO WORK WITH UNDRIVEN, TESTED WITH 3 DIFFERENT MORCELLATORS BUT STILL HAS E09 ERROR CODE. THE CUSTOMER RANG WHILST THEY WERE IN A PROCEDURE AND AFTER ADVISING TO USE ANOTHER MORCELLATOR TO SEE IF THE ISSUE PERSISTS, SHE CALLED BACK CONFIRMING THE ISSUE IS STILL THERE AND THEY HAD TO CANCEL THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 20869434 ↗
• InjuryDec 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE "FOOTPEDAL AND MORCELLATOR UNABLE TO WORK WITH UNIDRIVE, TESTED WITH 3 DIFFERENT MORCELLATORS BUT STILL HAS E09 ERROR CODE. THE CUSTOMER RANG WHILST THEY WERE IN A PROCEDURE AND AFTER ADVISING TO USE ANOTHER MORCELLATOR TO SEE IF THE ISSUE PERSISTS, SHE CALLED BACK CONFIRMING THE ISSUE IS STILL THERE AND THEY HAD TO CANCEL THE CASE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20868470 ↗