TRUCLEARTM ULTRA Plus Device 72203012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885554027617), received between Apr 13, 2018 and Oct 19, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2020Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PRODUCT DID NOT PERFORM ITS RECIPROCATING FUNCTION TO BE ABLE TO MAKE A RECESSION OF THE INTRA-UTERINE MYOMA. NO OTHER INSTRUMENT WAS USE AND THE PRODUCT WAS REMOVED FROM THE HAND PIECE. THE CASE WAS ABORTED, AND WAS RESCHEDULED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10696888 ↗
• InjuryAug 1, 2018Material Fragmentation; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Material Fragmentation

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO THE UTERUS DURING A HYSTEROSCOPIC MYOMECTOMY, THE INNER SHAFT OF THE DEVICE SPUN OUT AND WRAPPED AROUND THE OUTER TUBE OF THE DEVICE. IT WAS VERY SHARP AND JAGGED METAL. THIS RESULTED TO AN EXTENSION WITH THE SURGICAL TIME. NOTHING WAS DISENGAGED FROM THE HANDPIECE. IT WAS REQUIRED TO OPEN ANOTHER DEVICE AND AN X-RAY TO ENSURE NO MATERIAL FROM THE DEVICE WAS LEFT BEHIND IN CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THE PATIENT HAD NO POST OPERATIVE ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; Radiation Exposure, Unintended

  MAUDE report 7739253 ↗
• InjuryMay 16, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PIECE OF THE UNIT BROKE INTO THE PATIENT. BROKEN PIECES WAS LOCATED THROUGH HYSTEROSCOPY AND IT WAS RETRIEVED VIA GRASPERS. THE PROCEDURE WAS EXTENDED AND IT RAN ABOUT 2 AND A HALF HOURS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7520619 ↗
• MalfunctionApr 13, 2018Bent; Break; Detachment Of Device Component; Bent; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE BROKE WHILE RESECTING A 4CM SUBMUCOUS FIBROID. THE DEVICE STARTED JAMMING UP AND THEN IT APPEARED THAT THE RECIPROCATING BLADE WAS NO LONGER COMPLETELY WITHIN THE SHAFT. THE INSTRUMENT WAS REMOVED FROM THE PATIENT AND INSPECTED AND APPEARED BENT. THEY USED A SECOND DEVICE AND DURING THE PROCEDURE NOTICED A SMALL PIECE OF METAL INSIDE THE PATIENT'S UTERINE CAVITY. THE SURGEON MANUALLY ROTATED THE BROKEN DEVICE INTO AN OPEN POSITION TO USE IT FOR SUCTION AND PLACED IT BACK THROUGH THE HYSTEROSCOPE AND PLACED IT DIRECTLY OVER THE METAL FRAGMENT AND TURNED ON THE HANDPIECE SUCTION TO GET IT OUT OF THE CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7428972 ↗