Benesta Tissue Removal Device CAL-TR1511Recalls & reported problems
Caldera Medical, Inc. · The Benesta Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00857492008096), received between Jun 20, 2023 and Sep 11, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Material Separation2
- Dull, Blunt1
- Failure to Cut1
- Material Deformation1
- Material Twisted/Bent1
- Mechanical Problem1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Product Quality Problem; Dull, Blunt; Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735532 ↗MalfunctionNov 10, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
THE OUTER SHEATH CAME OFF PRIOR TO INSERTING THE TRD INTO THE HYSTEROSCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18116130 ↗MalfunctionJun 20, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
CALDERA REP NOTICED THE TRDS CUTTING WINDOW APPEARED "OPEN" EVEN THOUGH THE ACTIVATION BUTTON WAS NOT PRESSED. AS THE SURGEON ATTEMPTED TO GUIDE THE SCOPE AND TRD INTO OPTIMAL POSITION, THE OUTER TRD SHEATH BEGAN SLIDING OFF. SECOND TRD WAS USED AND PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17167439 ↗MalfunctionJun 20, 2023Material Separation; Material Deformation; Material Twisted/Bent; Material Separation; Material Deformation; Material Twisted/Bent
TRD OUTER CUTTER DETACHED FROM DEVICE DURING THE PROCEDURE. SECOND TRD WAS USED AND PROCEDURE WAS COMPLETED. CALDERA REP NOTICED THE OUTER CUTTER WAS BENT DURING THE PROCEDURE, CAUSED BY TORQUING THE DEVICE WHILE INSIDE THE WORKING CHANNEL OF THE HYSTEROSCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17167295 ↗
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- 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 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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