TRUCLEARTM INCISORTM Plus Device 7209509Recalls & reported problems
Smith & Nephew, Inc. · HYSTEROSCOPIC ROTARY MORCELLATOR · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010529459), received between Feb 6, 2019 and Feb 3, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Flaked” (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
Device problems
- Flaked2
- Contamination /Decontamination Problem1
- Material Discolored1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2021Flaked; Flaked
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICES HAD YELLOWISH FILM IN CUTTING WINDOW OF BLADE WHICH FLAKED OFF WHEN SCRATCHED WITH SCALPEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11271598 ↗MalfunctionFeb 3, 2021Flaked; Flaked
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICES HAD YELLOWISH FILM IN CUTTING WINDOW OF BLADE WHICH FLAKED OFF WHEN SCRATCHED WITH SCALPEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11271592 ↗MalfunctionFeb 6, 2019Material Discolored; Contamination /Decontamination Problem
5 DIFFERENT TRUCLEAR INCISOR PLUS DEVICES OPENED FROM STERILE PEEL PACK. THE TIPS OF INCISORS HAD BROWN DISCOLORATION AND DEBRIS (LINT). THIS WAS CAUGHT PRIOR TO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED AS PLANNED. THE REMAINING PACKS IN INVENTORY WERE INSPECTED AND REPLACED AS NECESSARY. MANUFACTURER RESPONSE FOR HYSTEROSCOPE (AND ACCESSORIES), TRUCLEAR TM INCISOR TM PLUS DEVICE (PER SITE REPORTER). THE FIELD REP WAS PRESENT AT THE TIME OF THE EVENT AND TOOK THE AFFECTED PRODUCTS.
Patient problems: No Patient Involvement
MAUDE report 8309944 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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