TruClear 72204878SRecalls & reported problems
Covidien LP · Elite Hysteroscope Mini, Refurbished · Class 2
Quick summary
This Covidien TruClear Elite mini hysteroscope is a refurbished scope used to look inside the uterus. Most of the 29 reports describe the scope tip breaking apart, with pieces of material sticking out or the tip bending, clouding, or chipping, sometimes leaving a sharp or jagged edge before or during use. None of the reports involved a patient. No deaths or injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10884521767744), received between Jan 12, 2021 and Sep 24, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (25 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.
Reports received per month
Most reported problems
Device problems
- Material Protrusion/Extrusion25
- Material Deformation8
- Material Opacification4
- Break3
- Detachment of Device or Device Component3
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Deformation; Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892025 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
It was reported that a scope had a chipped tip prior to use. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728088 ↗MalfunctionAug 31, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515054 ↗MalfunctionAug 3, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50122244 ↗MalfunctionJul 30, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084753 ↗MalfunctionJun 15, 2026Material Protrusion/Extrusion
IT WAS REPORTED THAT PRIOR TO USE, THE SCOPE WAS OBSERVED TO HAVE A SHARP DISTAL END. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25504775 ↗MalfunctionMar 20, 2026Material Protrusion/Extrusion
IT WAS REPORTED THAT DURING TESTING, THE TIP OF THE SCOPE WAS OBSERVED TO HAVE A SHARP EDGE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649542 ↗MalfunctionDec 15, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE BOTTOM OF THE SCOPE WAS JAGGED PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23800047 ↗MalfunctionOct 28, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE SCOPE HAD A SHARP EDGE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404808 ↗MalfunctionOct 27, 2025Material Opacification; Material Protrusion/Extrusion; Material Opacification; Material Protrusion/Extrusion
IT WAS REPORTED THAT A BLURRY SCOPE AND A POINTY, "SCRATCHY" TIP WERE OBSERVED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23396667 ↗MalfunctionOct 20, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT DISINTEGRATING MATERIAL AT THE SHAFT CONNECTION WAS OBSERVED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337010 ↗MalfunctionJul 31, 2025Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion
IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE, THE TIP OF THE SCOPE WAS FOUND TO BE DAMAGED AND SHARP. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676862 ↗MalfunctionJul 22, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE TIP OF THE SCOPE HAD A SHARP EDGE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22567052 ↗MalfunctionJul 9, 2025Material Opacification; Material Protrusion/Extrusion; Material Opacification; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, THE SCOPE HAD A SHARP TIP AND POOR VISUALIZATION. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22454842 ↗MalfunctionMay 5, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN INTRA-OPERATIVE PROCEDURE, A CHIP WAS OBSERVED AT THE FRONT OF THE SCOPE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21958288 ↗MalfunctionApr 10, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE DEVICE HAD A SHARP TIP DURING PRE-OPERATIVE PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21814916 ↗MalfunctionDec 12, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, THE HANDPIECE HAD TWO "CUTS" IN THE CORD, AND THE DISTAL END OF THE SCOPE WAS SHARP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20912941 ↗MalfunctionOct 2, 2024Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, PRIOR TO USE, THE SCOPE HAD RIGGED AND SHARP TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20352070 ↗MalfunctionSep 5, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, DURING DEMO, THE UNIT SCOPE TIP IS SHARP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20150256 ↗MalfunctionAug 23, 2024Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, PRIOR TO USE, THE SCOPE HAD BENT JAGGERED TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20054891 ↗MalfunctionAug 23, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A SHARP TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20049823 ↗MalfunctionDec 28, 2023Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, THE HYSTEROSCOPE'S SHAFT HAD CRACKED AND SHARP EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18407411 ↗MalfunctionDec 5, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, THE SCOPE HAD JAGGED TIP OF THE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18270990 ↗MalfunctionOct 16, 2023Break; Break
ACCORDING TO THE REPORTER, THE DEVICE'S SHAFT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17940856 ↗MalfunctionSep 8, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, DURING DEMO, THE DEVICE HAD A SHARP METAL STICKING OUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17716499 ↗
Other HYSTEROSCOPE (AND ACCESSORIES) devices
- Olympus WA2T430AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)783 reports
- Olympus WA2T412AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)453 reports
- Olympus A22001AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)366 reports
- Olympus WA2T470AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)323 reports
- Olympus A22002AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)297 reports
- Olympus A22003AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)198 reports
- n.a. 27040XAKarl Storz GmbH & Co. KG · HYSTEROSCOPE (AND ACCESSORIES)102 reports
- Myosure Reach Tissue Removal Device 10-401FCHologic, Inc. · HYSTEROSCOPE (AND ACCESSORIES)4 deaths99 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.