TruClear 72204752 (UDI 00885556583654)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556583654), received between Dec 14, 2023 and May 24, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (1 report).

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.

• MalfunctionMay 24, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, DURING SERVICING, THE UNIT WAS FOR PREVENTATIVE MAINTENANCE. PM CHECKS CARRIED OUT. VISUAL INSPECTION GOOD. BUT CODED WITH INSTRUMENT WITH SHARP EDGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393004 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY EVALUATED THE EFFECTIVENESS, SAFETY AND PATIENT SATISFACTION OF HYSTEROSCOPIC REMOVAL OF RETAINED PRODUCTS OF CONCEPTION BETWEEN MARCH 2022 AND DECEMBER 2022. TRUCLEAR 5C HYSTEROSCOPE WITH SOFT TISSUE SHAVER MINI OR A COMPETITOR DEVICE WAS USED. THERE WERE 52 HYSTEROSCOPIES PERFORMED AND TRUCLEAR WAS USED IN 7 PROCEDURES. COMPLICATIONS INCLUDED BLEEDING AND PERFORATION. ONE CASE WAS NOT COMPLETED DUE TO UTERINE BLEEDING CAUSING POOR VISUALIZATION AND THE PATIENT REQUIRED A SECOND HYSTEROSCOPIC PROCEDURE UNDER GENERAL ANESTHESIA. TWO CASES OF UTERINE BLEEDING REQUIRED USE OF AN INTRAUTERINE FOLEY BALLOON AND INTRAVENOUS TRANEXAMIC ACID. AFTER 3 HOURS, THE BALLOON WAS REMOVED AND BOTH PATIENTS WERE DISCHARGED THE SAME DAY. ONE UTERINEPERFORATION OCCURRED REQUIRING A LAPAROSCOPY WHICH IDENTIFIED A BOWEL PERFORATION WHICH WAS CLOSED WITH STITCHES. THE PATIENT WAS DISCHARGED 3 DAYS LATER WITHOUT ANY OTHER ADVERSE EVENTS. IT WAS NOT SPECIFIED WHICH DEVICE ATTRIBUTED TO THE REPORTED EVENTS.

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding; Uterine Perforation

  MAUDE report 18327034 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY EVALUATED THE EFFECTIVENESS, SAFETY AND PATIENT SATISFACTION OF HYSTEROSCOPIC REMOVAL OF RETAINED PRODUCTS OF CONCEPTION BETWEEN MARCH 2022 AND DECEMBER 2022. TRUCLEAR 5C HYSTEROSCOPE WITH SOFT TISSUE SHAVER MINI OR A COMPETITOR DEVICE WAS USED. THERE WERE 52 HYSTEROSCOPIES PERFORMED AND TRUCLEAR WAS USED IN 7 PROCEDURES. COMPLICATIONS INCLUDED BLEEDING AND PERFORATION. ONE CASE WAS NOT COMPLETED DUE TO UTERINE BLEEDING CAUSING POOR VISUALIZATION AND THE PATIENT REQUIRED A SECOND HYSTEROSCOPIC PROCEDURE UNDER GENERAL ANESTHESIA. TWO CASES OF UTERINE BLEEDING REQUIRED USE OF AN INTRAUTERINE FOLEY BALLOON AND INTRAVENOUS TRANEXAMIC ACID. AFTER 3 HOURS, THE BALLOON WAS REMOVED AND BOTH PATIENTS WERE DISCHARGED THE SAME DAY. ONE UTERINEPERFORATION OCCURRED REQUIRING A LAPAROSCOPY WHICH IDENTIFIED A BOWEL PERFORATION WHICH WAS CLOSED WITH STITCHES. THE PATIENT WAS DISCHARGED 3 DAYS LATER WITHOUT ANY OTHER ADVERSE EVENTS. IT WAS NOT SPECIFIED WHICH DEVICE ATTRIBUTED TO THE REPORTED EVENTS.

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding; Uterine Perforation

  MAUDE report 18326991 ↗