TruClear 72204878Recalls & reported problems
Covidien LP · Elite Hysteroscope Mini · Class 2
Quick summary
This TruClear Elite Hysteroscope Mini has 40 adverse event reports, including 39 malfunctions, no deaths, and 1 injury. Reports mostly describe scopes breaking, bending, cracking, or developing sharp metal edges, with patient harm rare. No recalls name this device. Report counts fell from 6 in the prior 12 months to 0 in the most recent 12 months.
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
- 42
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10884521746633), received between Jul 8, 2019 and Sep 11, 2026 — classified as 1 injury, 41 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (28 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/Extrusion28
- Material Deformation9
- Detachment of Device or Device Component5
- Break4
- Material Opacification4
- Adverse Event Without Identified Device or Use Problem3
- Contamination1
- Device Reprocessing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Patient Involvement7
- No Information5
- Insufficient Information1
- No Code Available1
- Perforation1
- Superficial (First Degree) Burn1
- Uterine Perforation1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Material Protrusion/Extrusion
It was reported that during demonstration, the device had a broken shaft where there was a sharp edge on the bevel. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50726857 ↗MalfunctionSep 8, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671108 ↗MalfunctionAug 17, 2025Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion
IT WAS REPORTED THAT AFTER PROCEDURE, A SCOPE WAS FOUND TO BE INTERNALLY CURVED AND TO HAVE METAL BURRS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22824315 ↗MalfunctionJul 7, 2025Material Opacification; Material Deformation; Material Protrusion/Extrusion; Material Opacification; Material Deformation; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, THE SCOPE WAS DAMAGED INTERNALLY, HAD AN IMAGE DISTORTION AND OUTSIDE SHARP METAL ON THE SHAFT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22412623 ↗MalfunctionMay 29, 2025Device Reprocessing Problem; Contamination; Detachment of Device or Device Component; No Apparent Adverse Event; Device Reprocessing Problem; Contamination; Detachment of Device or Device Component; No Apparent Adverse Event
ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY POLYPECTOMY PROCEDURE, THE SURGEON WAS CONDUCTING A HYSTEROSCOPY USING THE DEVICE AND HYSTEROSCOPE INITIALLY IN IDENTIFYING PATHOLOGY. AS DETERMINED TO USE THE SOFT TISSUE MINI SHAVER TO REMOVE AND BIOPSY POLYP, UPON ENTERING THE SHAVER INTO AND THROUGH THE HYSTEROSCOPE IT BECAME VISIBLE THAT A FOREIGN OBJECT WAS PUSHED OUT AND IMMEDIATELY DETECTED AND REMOVED BY THE SURGEON. A PIECE FELL INTO THE PATIENT'S CAVITY AND IT WAS RETRIEVED. THERE WAS NO X-RAY PERFORMED, AND NO ADDITIONAL MEDICAL PROCEDURE WAS NEEDED. IT WAS CONFIRMED VIA PATHOLOGY REPORT RECEIVED THAT FOREIGN BODY WAS DETERMINED TO BE AN ¿ENDOMETRIAL POLYP WITH DEGENERATIVE CHANGES¿ AND HAD FURTHER INDICATED THAT IT WAS ATTRIBUTED TO ¿WASN¿T CLEANED APPROPRIATELY¿. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22111124 ↗MalfunctionMay 29, 2025Break; Break
IT WAS REPORTED THAT DURING INTRA-OPERATIVE PROCEDURE, A SCOPE EXPERIENCED A CRACKED SHAFT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22110692 ↗MalfunctionApr 30, 2025Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion
IT WAS REPORTED THAT A SHARP-EDGED DISTAL END AND BROKEN TIP WAS OBSERVED ON THE PRODUCT.
Patient problems: Insufficient Information
MAUDE report 21939539 ↗MalfunctionMar 18, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE TIP OF A SCOPE WAS SHARP. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21635272 ↗MalfunctionOct 2, 2024Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, THE UNIT TIP OF SCOPE BENT AND SHARP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20351838 ↗MalfunctionApr 18, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, THE DEVICE HAD A JAGGED EDGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19137918 ↗MalfunctionApr 11, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, THE DEVICE HAD A BURR ON DISTAL TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19091355 ↗MalfunctionFeb 29, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS A SHARP AREA ON TIP OF SCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18810392 ↗MalfunctionNov 7, 2023Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, PRIOR TO USE, THE BARREL OF THE SCOPE WAS BENT, PREVENTING THE WORKING CHANNEL FROM BEING INSERTED. IT IS ALSO BENT AT THE END OF THE SCOPE CAUSING A SHARP EDGE THAT WOULD CUT A PATIENT IF INSERTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18086580 ↗MalfunctionMay 25, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, THE BURR ON TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17003817 ↗MalfunctionFeb 9, 2023Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, THE DISTAL TIP SPLIT AND HAD SHARP EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16332644 ↗MalfunctionNov 22, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, PRIOR TO USE, THE END OF SCOPE WAS ROUGH OR SHARP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15845742 ↗MalfunctionSep 29, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, PRIOR TO USE, THE TIP IS SHARP, TOO SHARP TO USE COULD CUT TISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15506187 ↗MalfunctionSep 28, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, DURING FACILITY SERVICING, THE DISTAL TIP OF THE SCOPE WAS VERY SHARP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15496065 ↗MalfunctionNov 15, 2021Break; Break
ACCORDING TO THE REPORTER, THE LONG SHAFT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12813308 ↗MalfunctionNov 4, 2021Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE DEVICE SCOPE HAS HAIR LINE FRACTURE AND LEFT ONE INCH BURN ON PATIENT.
Patient problems: Superficial (First Degree) Burn
MAUDE report 12751731 ↗MalfunctionSep 26, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD SHARP EDGE ON TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12531149 ↗MalfunctionAug 24, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, DURING USE, THE TIP OF UNIT HAS A ROUGH EDGE ON IT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12359795 ↗MalfunctionJun 29, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD SHARP EDGE AT THE TIP. THERE WAS WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12089876 ↗MalfunctionJun 29, 2021Material Opacification; Material Protrusion/Extrusion; Material Opacification; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A FOGGY LENS AND A SHARP AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12089716 ↗MalfunctionJun 7, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SCOPE WAS NOT SMOOTH AT THE END. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11950562 ↗
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.