TruClear 72202536Recalls & reported problems
Covidien LP · Soft Tissue Shaver Mini · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien TruClear Soft Tissue Shaver Mini is a rotating blade used inside a hysteroscope to cut tissue during uterine procedures. Most of its 47 reports describe the blade or tip breaking apart during surgery, sometimes with small pieces falling near or into the patient, along with blades detaching, jamming, or spinning too fast. There are10 injuries and no deaths. 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
- 48
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884521744080), received between Dec 3, 2018 and Sep 8, 2026 — classified as 10 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (20 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 Fragmentation20
- Detachment of Device or Device Component13
- Adverse Event Without Identified Device or Use Problem10
- Mechanical Jam4
- Suction Problem4
- Appropriate Device Problem Term/Code Not Available3
- Break2
- Fail-Safe Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- No Consequences Or Impact To Patient6
- Insufficient Information4
- Hemorrhage/Blood Loss/Bleeding2
- Unspecified Tissue Injury2
- Muscle/Tendon Damage1
- No Code Available1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Detachment of Device or Device Component
It was reported that during the procedure, the inner-tube of the blade was broken. The fracture occurred inside the handpiece. No device fragments detached or entered the patient's body. They completed the procedure with an alternative method. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50668659 ↗MalfunctionMay 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, PRIOR TO A HYSTEROSCOPY AND CURETTAGE PROCEDURE, UNIDENTIFIED FRAGMENTS WERE OBSERVED FALLING FROM THE SHAVER TIP. THE SHAVER WAS REPLACED WITH A NEW SHAVER TO CONTINUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150957 ↗MalfunctionMay 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING HYSTEROSCOPY, A DEVICE COMPLETELY BROKE OFF. THE PHYSICIAN STATED THAT THE SHAVER WAS NOT USED AGGRESSIVELY OR ROUGHLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25081184 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SOFT TISSUE SHAVER MINI BLADE SNAPPED IN TWO DURING REMOVAL FROM THE SCOPE AT THE END OF THE PROCEDURE AFTER THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290658 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A POLYPECTOMY, AFTER APPROXIMATELY ONE MINUTE OF SHAVERING WITHIN THE UTERUS, A SMALL PIECE OF MATERIAL THAT APPEARED METALLIC WAS OBSERVED (FOR 3 TO 5 SECONDS) BEFORE DISAPPEARING. THIS EVENT RAISED CONCERN THAT THE PIECE COULD HAVE BEEN PART OF THE SHAVER. THE PROCEDURE WAS IMMEDIATELY PAUSED, AND A SECOND BLADE WAS USED TO COMPLETE THE CASE. UPON RE-ENTERING THE UTERUS, THE METALLIC PIECE WAS NO LONGER VISIBLE, AND THE PROCEDURE WAS FINISHED WITHOUT FURTHER INCIDENT. IT WAS THOUGHT THAT THE PIECE MAY HAVE BEEN SUCKED BY THE VACUUM AND TRAPPED IN THE TISSUE TRAP, WHICH WAS SENT TO THE LAB FOR INVESTIGATION FOR ANY NON-BIOLOGICAL MATERIAL. NO X-RAY IMAGING WAS PERFORMED TO LOCATE OR CONFIRM THE PRESENCE OF THE COMPONENT. BOTH BLADES USED DURING THE PROCEDURE WERE ALSO SENT FOR INVESTIGATION TO DETERMINE IF ANY PARTS WERE MISSING. NO MEDICAL OR SURGICAL INTERVENTION WAS NECESSARY, AND THERE WERE NO ADVERSE OUTCOMES SUCH AS PERMANENT IMPAIRMENT, EXTENDED HOSPITALIZATION, UNANTICIPATED TISSUE LOSS OR DAMAGE, SIGNIFICANT BLOOD LOSS, OR PROLONGED SURGICAL TIME. NO ADDITIONAL OPERATIONS WERE PLANNED, AND NO PATIENT INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23052110 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A POLYPECTOMY, AFTER APPROXIMATELY ONE MINUTE OF SHAVERING WITHIN THE UTERUS, A SMALL PIECE OF MATERIAL THAT APPEARED METALLIC WAS OBSERVED (FOR 3 TO 5 SECONDS) BEFORE DISAPPEARING. THIS EVENT RAISED CONCERN THAT THE PIECE COULD HAVE BEEN PART OF THE SHAVER. THE PROCEDURE WAS IMMEDIATELY PAUSED, AND A SECOND BLADE WAS USED TO COMPLETE THE CASE. UPON RE-ENTERING THE UTERUS, THE METALLIC PIECE WAS NO LONGER VISIBLE, AND THE PROCEDURE WAS FINISHED WITHOUT FURTHER INCIDENT. IT WAS THOUGHT THAT THE PIECE MAY HAVE BEEN SUCKED BY THE VACUUM AND TRAPPED IN THE TISSUE TRAP, WHICH WAS SENT TO THE LAB FOR INVESTIGATION FOR ANY NON-BIOLOGICAL MATERIAL. NO X-RAY IMAGING WAS PERFORMED TO LOCATE OR CONFIRM THE PRESENCE OF THE COMPONENT. BOTH BLADES USED DURING THE PROCEDURE WERE ALSO SENT FOR INVESTIGATION TO DETERMINE IF ANY PARTS WERE MISSING. NO MEDICAL OR SURGICAL INTERVENTION WAS NECESSARY, AND THERE WERE NO ADVERSE OUTCOMES SUCH AS PERMANENT IMPAIRMENT, EXTENDED HOSPITALIZATION, UNANTICIPATED TISSUE LOSS OR DAMAGE, SIGNIFICANT BLOOD LOSS, OR PROLONGED SURGICAL TIME. NO ADDITIONAL OPERATIONS WERE PLANNED, AND NO PATIENT INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23052068 ↗MalfunctionJul 29, 2025Material Fragmentation; Detachment of Device or Device Component; Mechanical Jam; Material Fragmentation; Detachment of Device or Device Component; Mechanical Jam
ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY POLYPECTOMY, DILATATION AND CURETTAGE WITH PELVIC EXAM UNDER ANESTHESIA, THE SURGEON INTRODUCED THE MINI TISSUE SHAVER AND THEN PERFORMED RESECTION OF THE TISSUE UNDER DIRECT VISUALIZATION. DURING THE MIDPOINT OF THE RESECTION OF THE TISSUE. THE SHAVER BLADE JAMMED, AND THE DEVICE WAS NOT FUNCTIONAL, SO IT WAS REMOVED. A SMALL, BRIGHT, SHINY (METAL-LOOKING) ITEM WAS OBSERVED. THE SHAVER WAS CHECKED, AND A SMALL PIECE WAS MISSING. THE CAVITY WAS SUCTIONED AND DRAINED, AND A NEW TISSUE SHAVER WAS OBTAINED, AND THE RESECTION WAS COMPLETED. NO X-RAY WAS PERFORMED, AS THE BROKEN PIECE WAS TOO SMALL TO BE DETECTED, AND NO ADDITIONAL MEDICAL PROCEDURE WAS NEEDED TO REMOVE THE PIECE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22641172 ↗MalfunctionJul 11, 2025Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A VAGINAL HYSTEROSCOPY (DILATION AND CURETTAGE) FOR POLYP RESECTION PROCEDURE, THE INTERNAL SHEATH OF THE SHAVER JUMPED OR ROTATED TOO FAST INSTEAD OF ROTATING SLOWLY WHEN THE WINDOW LOCK WAS ACTIVATED. THE SHAVER CONTINUED TO JUMP OR OSCILLATE INSTEAD OF WINDOW LOCKING APPROPRIATELY AFTER RESEATING THE SHAVER IN THE HANDPIECE AND UNPLUGGING AND REPLUGGING THE HANDPIECE TO THE CONTROL UNIT. A SECOND SOFT TISSUE MINI SHAVER FROM THE SAME LOT WAS OPENED AND EXHIBITED THE SAME WINDOW LOCK ISSUE. A DENSE BLADE WAS THEN OPENED, BUT THE SURGEON ULTIMATELY SWITCHED TO A CURETTE TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22476705 ↗MalfunctionJul 11, 2025Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A VAGINAL HYSTEROSCOPY (DILATION AND CURETTAGE) FOR POLYP RESECTION PROCEDURE, THE INTERNAL SHEATH OF THE SHAVER JUMPED OR ROTATED TOO FAST INSTEAD OF ROTATING SLOWLY WHEN THE WINDOW LOCK WAS ACTIVATED. THE SHAVER CONTINUED TO JUMP OR OSCILLATE INSTEAD OF WINDOW LOCKING APPROPRIATELY AFTER RESEATING THE SHAVER IN THE HANDPIECE AND UNPLUGGING AND RE-PLUGGING THE HANDPIECE TO THE CONTROL UNIT. A SECOND SOFT TISSUE MINI SHAVER FROM THE SAME LOT WAS OPENED AND EXHIBITED THE SAME WINDOW LOCK ISSUE. THE DISTENSION WAS LOST. A DENSE BLADE WAS THEN OPENED AND WORKED PROPERLY. HOWEVER, THE SURGEON ULTIMATELY SWITCHED TO A CURETTE TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22476681 ↗MalfunctionApr 17, 2025Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPIC DILATION AND CURETTAGE (D<(>&<)>C) PROCEDURE, ON THE LAPAROSCOPIC MONITOR THERE WAS A SPARKELY GLITTER WITHIN THE UTERINE CAVITY AND A FEW SMALL SCATTERED FLECKS.. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21861565 ↗MalfunctionJan 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING OPERATIVE HYSTEROSCOPY PROCEDURE, THE INNER SHEATH WITH THE BLACK LINE SNAPPED OFF WHILE WINDOW LOCKING THE INSTRUMENT INSIDE THE CAVITY. THE TIP OF THE INNER COMPONENT OF THE SHAVER FELL INTO THE CAVITY BUT EXPELLED ITSELF NATURALLY OUT OF THE CERVICAL CANAL AT THE END OF THE CASE. THERE WAS NO X-RAY PERFORMED AND NO ADDITIONAL OPERATION PERFORMED. THEY USED SALINE TO WASH IT OUT OF THE CAVITY TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21112338 ↗MalfunctionOct 19, 2024Break; Suction Problem; Break; Suction Problem
ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY, THE DEVICE WAS NOT SUCTIONING DURING RESECTION AND THE STEM BROKE/SNAPPED UPON REMOVAL. NO DEVICE COMPONENT FELL INTO THE PATIENT'S CAVITY BUT THERE WAS AN UNANTICIPATED TISSUE LOSS AS A RESULT OF THE PROBLEM.
Patient problems: Tissue Breakdown; Unspecified Tissue Injury
MAUDE report 20489098 ↗MalfunctionJul 24, 2023Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, DURING HYSTEROSCOPIC POLYPECTOMY, THE DEVICE WAS INSERTED INTO THE UTERINE CAVITY. SUBSEQUENTLY, A SMALL PIECE OF BLACK MATERIAL FLOATED OUT OF THE TIP. THE MATERIAL WAS HARD TO TELL IF IT WAS METAL OR PLASTIC FROM THE CAP THAT HAD BEEN REMOVED. THE SURGEON IMMEDIATELY USED THE SHAVER TO SUCK UP THE SMALL PIECE OF MATERIAL AND PROCEEDED WITH THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17377034 ↗MalfunctionJul 17, 2023Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, DURING PROCEDURE, THERE WAS A METAL COMING WAS FROM THE INSIDE OF THE SHAVER DEVICE. THROW THE DEVICE AWAY AND GOT A NEW ONE. NOT SURE IF THE METAL WAS COMING FROM. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17339411 ↗MalfunctionJul 7, 2023Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY, RESECTION OF POLYP, THE SURGEON NOTICED "GLISTENING METAL SHAVINGS", ONCE IT WAS NOTICED, RESECTION WITH THE TRUCLEAR DEVICE WAS STOPPED AND A REGULAR D AND C (DILATE AND CURETTAGE) WAS PERFORMED. PIECES OF THE "METAL SHAVINGS" WERE RETRIEVED WHILE PERFORMING D AND C. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17283422 ↗MalfunctionJun 29, 2023Contamination; Material Fragmentation; Contamination; Material Fragmentation
ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY, THERE WAS A FOREIGN MATERIAL THAT CAME FROM THE PART OF THE SCOPE WHEN THE PHYSICIAN WAS WINDOW LOCKING. THE PARTICLE WAS SUCKED INTO THE BLADE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17233012 ↗InjuryApr 27, 2023Suction Problem; Appropriate Device Problem Term/Code Not Available; Suction Problem; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY, THE DEVICE THE BLADE ROTATED, THE SOUND WAS HEARD BUT DID NOT SUCK. PROBLEM WITH PATIENT WHO HAD TO BE RESCHEDULED FOR ANOTHER HYSTEROSCOPY DUE TO POSSIBLE CARCINOMA. PATIENT WAS NOT UNDER ANY SEDATION OR ANESTHESIA DURING THIS HYSTEROSCOPY. PATIENT WAS RESCHEDULED AND CONFIRMED THE DIAGNOSTICS THE OTHER DAY. USED A DIFFERENT HANDPIECE HANDPIECE BUT DID NOT PROVIDE LOT NUMBER. THE PROBLEM WAS THE BLADE WITH THE SAME LOT NUMBER IN THE SAME CUSTOMER. THERE WAS NO INJURY.
Patient problems: Insufficient Information
MAUDE report 16828566 ↗InjuryApr 27, 2023Suction Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Suction Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE THE BLADE ROTATED, THE SOUND WAS HEARD BUT DID NOT SUCK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16828554 ↗MalfunctionMar 6, 2023Defective Device; Material Deformation; Appropriate Device Problem Term/Code Not Available; Defective Device; Material Deformation; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY, THE DEVICE WAS BROKEN. WHILE USING SHAVER, BLADE HOUSING SNAPPED. INTACT. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. REPLACED WITH THE SAME DEVICE AND WORKED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16483895 ↗MalfunctionFeb 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY, DURING ENTRY OF STM (SOFT TISSUE MINI) SHAVER INTO THE UTERUS, A SMALL PIECE OF RUBBERY MATERIAL MADE ITS WAY INTO THE PATIENT'S UTERUS. THE MATERIAL WAS SENT TO LAB AND REPORT STATED IT WAS NOT BLOOD, BUT A RUBBERY MATERIAL. THE PHYSICIAN USED A NEW STM (SOFT TISSUE MINI) SHAVER AND THE RUBBERY PLASTIC OBJECT WAS REMOVED FROM UTERUS AND WAS ABLE TO COMPLETE A SUCCESSFUL HYSTEROSCOPY, NO X-RAY WAS PERFORMED AND NO ADDITIONAL PROCEDURE WAS NEEDED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16433072 ↗InjuryOct 20, 2022Difficult or Delayed Activation; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Activation; Mechanical Jam; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPIC ENDOMETRIAL POLYPECTOMY, WHEN THE FOOT PEDAL WAS STEPPED ON TO SHAVE A POLYP, THE SHAVER DID NOT MOVE AT HIGH SPEED AS USUAL, AND IT FELT LIKE IT WAS GETTING STUCK AND SO THEY STOPPED. THE POWER WAS TURNED OFF AND RESTARTED AFTER ABOUT 30 SECONDS; THIS TIME, THE SAME MOVEMENT OCCURRED EVEN WHEN THE WINDOW LOCK BUTTON WAS PRESSED, AND EVEN WHEN THE FOOT PEDAL WAS PRESSED, IT WAS THE SAME AS BEFORE. SHAVING THE POLYP A LITTLE BIT AS IS WAS ATTEMPTED, BUT IT COULD NOT BE SHAVED AS EXPECTED. THE POWER WAS TURNED OFF AND RESTARTED AGAIN, BUT IT DID NOT IMPROVE JUST LIKE THE SITUATION ABOVE. IT WAS DETERMINED THAT THE OPERATION COULD NOT BE CONTINUED; THE OPERATION WAS PERFORMED MIDWAY, BUT THE OPERATION WAS DISCONTINUED AND A RE-OPERATION WAS SCHEDULED FOR ANOTHER DAY. THEY HAVE ALSO POSTPONED TOMORROW'S OPERATION BECAUSE THE REPLACEMENT MACHINE WILL NOT ARRIVE IN TIME. IT WAS POSSIBLE THAT THE OTHER ASSOCIATED DEVICES SUCH AS CONTROL UNIT, FOOT SWITCH AND HANDPIECE WAS DEFECTIVE/PROBLEM. THERE WAS NO PATIENT INJURY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15639111 ↗InjuryOct 18, 2022Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING POLYPECTOMY, DURING THE INITIAL STAGE OF WINDOW LOCKING IN THE UTERUS, THE TWO DEVICES WOULD NOT ROTATE OR MOVE. IT SEEMED TO BE BOUND UP. THE CASE WAS ABORTED AND HYSTEROSCOPY WAS RESCHEDULED THE SAME DAY. A DENSE TISSUE MINI SHAVER WAS USED AND WORKED FINE. ADDITIONALLY, A SOFT TISSUE MINI DEVICES WERE USED THE NEXT DAY WITH NO ISSUE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15626222 ↗InjuryOct 10, 2022Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING POLYPECTOMY, DURING THE INITIAL STAGE OF WINDOW LOCKING IN THE UTERUS, THE TWO DEVICES WOULD NOT ROTATE OR MOVE. IT SEEMED TO BE BOUND UP. THE CASE WAS ABORTED AND HYSTEROSCOPY WAS RESCHEDULED THE SAME DAY. A DENSE TISSUE MINI SHAVER WAS USED AND WORKED FINE. ADDITIONALLY, A SOFT TISSUE MINI DEVICES WERE USED THE NEXT DAY WITH NO ISSUE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15571962 ↗MalfunctionJun 2, 2022Suction Problem; Adverse Event Without Identified Device or Use Problem; Suction Failure; Suction Problem; Adverse Event Without Identified Device or Use Problem; Suction Failure
ACCORDING TO THE REPORTER, DURING SHAVERING A POLYP IN A HYSTEROSCOPY PROCEDURE, THERE WAS NO PATHOLOGY SUCKED IN THE DEVICE. THEY STOPPED THE PROCEDURE AND TESTED THE VACUUM (DIFFERENT SETTINGS WERE TESTED (WINDOW LOCK, FULL VACUUM)). IT LOOKED LIKE THE SHAVER WAS CLOGGED AS IT WOULD NOT SUCK UP ANY LIQUID. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS NOT COMPLETED AS THERE WAS NO OTHER BLADES AVAILABLE BUT THERE WAS NO PATIENT INJURY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 14584858 ↗MalfunctionApr 11, 2022Material Fragmentation; Material Fragmentation
ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY, THE SHAVER LEFT METAL FRAGMENTS IN CAVITY OF UTERUS. METAL SHAVINGS WERE RETRIEVED. PROCEDURE COMPLETED AFTER PATHOLOGY WAS RESECTED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14074701 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page