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TruClear 72204064Recalls & reported problems

Covidien LP · Dense Tissue Shaver Mini · Class 2

Quick summary

This Covidien TruClear Dense Tissue Shaver is a hand-held cutting tool used inside a hysteroscope to remove uterine tissue such as fibroids and polyps. The 29 reports mostly describe blades and shafts breaking or snapping during surgery, blades that spin or lock up without cutting, and small pieces breaking off and having to be retrieved from the uterus. Eight reports mention injuries; no deaths were reported. 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
29
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884521744097), received between Sep 15, 2017 and May 13, 2026 — classified as 8 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component9
  • Failure to Cut7
  • Appropriate Device Problem Term/Code Not Available6
  • Material Fragmentation6
  • Adverse Event Without Identified Device or Use Problem5
  • Break3
  • Fail-Safe Problem3
  • Material Deformation3

Patient problems

  • No Clinical Signs, Symptoms or Conditions11
  • Insufficient Information6
  • No Known Impact Or Consequence To Patient5
  • No Consequences Or Impact To Patient4
  • Blood Loss1
  • Device Embedded In Tissue or Plaque1
  • Exsanguination1
  • No Code Available1

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 13, 2026Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A HYSTEROSCOPY WITH DEVICE FOR FIBROID RESECTION, THE DEVICE SHAFT BROKE NEAR THE PLASTIC PIECE WHILE THE MINI DENSE BLADE WAS BEING USED, WITH THE SHAFT BREAKING OFF OF THE PLASTIC PART. ANOTHER SHAVER WAS USED TO COMPLETE THE PROCEDURE. NO DEVICE COMPONENT FELL INTO THE PATIENT CAVITY. X-RAY WAS NOT NEEDED TO FIND AND RETRIEVE THE BROKEN PIECE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25158338 ↗
  • MalfunctionJan 7, 2026Break

    IT WAS REPORTED THAT DURING AN OPERATIVE HYSTEROSCOPY, THE DEVICE EXHIBITED A BROKEN METAL SHAFT AT THE BASE WHERE IT CONNECTS TO THE PLASTIC CONNECTOR THAT ATTACHES TO THE SHAVER HANDPIECE. THE DEVICE WAS NOT APPLIED TO THE PATIENT; IT WAS ONLY INSERTED INTO THE HANDPIECE AND REPLACED WITH A NEW BLADE. THE CASE WAS COMPLETED WITH A SECOND UNIT. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23988803 ↗
  • MalfunctionNov 10, 2025Contamination; Detachment of Device or Device Component; Contamination; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A MYOMECTOMY (HYSTEROSCOPY) PROCEDURE, A SMALL BLACK RINGED FOREIGN OBJECT WAS NOTICED INSIDE THE UTERUS AFTER THE DEVICE HAD BEEN INSERTED. A SMALL BLACK RING OBJECT, FELL INTO THE CAVITY OF THE PATIENT. AN ALPHA SCOPE WAS USED TO RETRIEVE THE FOREIGN OBJECT FROM THE PATIENT. NO X-RAY WAS PERFORMED TO LOCATE OR CONFIRM RETRIEVAL OF THE COMPONENT AND NO ADDITIONAL OPERATION WAS REQUIRED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23512828 ↗
  • MalfunctionSep 3, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BLADE BENT AND SNAPPED OFF. THE INNER SHEATH STAYED CONNECTED TO THE HANDPIECE, WHILE THE OUTER SHEATH BROKE OFF AND REMAINED LODGED IN THE SCOPE WHEN THE HANDPIECE WAS REMOVED. THERE WAS NO PIECE FELL INTO THE PATIENT CAVITY, NO X-RAY WAS PERFORMED, AND NO ADDITIONAL MEDICAL PROCEDURE NEEDED TO REMOVE THE PIECE FROM THE PATIENT. REPLACED WITH ANOTHER DEVICE, AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22949463 ↗
  • MalfunctionJul 10, 2025Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

    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 22469320 ↗
  • MalfunctionOct 28, 2024Failure to Cut; Appropriate Device Problem Term/Code Not Available; Failure to Cut; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE REPORTER, DURING PROCEDURE, UPON SHAVER INSERTION AND ACTIVATION OF THE FOOT PEDAL, THE BLADE ROTATED BUT DID NOT R ESECT/SHAVE. USED ANOTHER SHAVER BUT IT FAILED TOO. THE PROCEDURE WAS ABORTED.

    Patient problems: Insufficient Information

    MAUDE report 20553186 ↗
  • MalfunctionOct 28, 2024Failure to Cut; Appropriate Device Problem Term/Code Not Available; Failure to Cut; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE REPORTER, DURING PROCEDURE, UPON SHAVER INSERTION AND ACTIVATION OF THE FOOT PEDAL, THE BLADE ROTATED BUT DID NOT R ESECT/SHAVE. USED ANOTHER SHAVER BUT IT FAILED TOO. THE PROCEDURE WAS ABORTED.

    Patient problems: Insufficient Information

    MAUDE report 20552271 ↗
  • InjurySep 25, 2024Fail-Safe Problem; Material Deformation; Appropriate Device Problem Term/Code Not Available; Fail-Safe Problem; Material Deformation; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY MYOMECTOMY, THE DEVICE INITIALLY WORKED AND SUB-OPTIMALLY RESECTED MYOMA TISSUE UNTIL IT COMPLETELY LOCKED UP. THE CUTTING WINDOW NO LONGER MOVED WHEN ACTIVATING THE FOOTSWITCH. TOOK SHAVER OUT OF HANDPIECE AND THE HANDPIECE WORKED FINE. IT WAS AS IF THE SLOUGH CHAMBER COMPLETELY LOCKED OR WAS BROKEN. OPENED A NEW SHAVER AND THE SAME ISSUE HAPPENED WITHIN 15 SECONDS. THE PROCEDURE WAS ABORTED DUE TO PROLONGED PROCEDURE TIME; MORE THAN 30 MINUTES, AND THE PATIENT ABSORBING TOO MUCH FLUID FROM THE DELAY. ADDITIONAL OPERATION WILL BE PERFORMED.

    Patient problems: Insufficient Information

    MAUDE report 20303748 ↗
  • InjurySep 25, 2024Fail-Safe Problem; Material Deformation; Appropriate Device Problem Term/Code Not Available; Fail-Safe Problem; Material Deformation; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY MYOMECTOMY, THE DEVICE INITIALLY WORKED AND SUB-OPTIMALLY RESECTED MYOMA TISSUE UNTIL IT COMPLETELY LOCKED UP. THE CUTTING WINDOW NO LONGER MOVED WHEN ACTIVATING THE FOOTSWITCH. TOOK SHAVER OUT OF HANDPIECE AND THE HANDPIECE WORKED FINE. IT WAS AS IF THE SLOUGH CHAMBER COMPLETELY LOCKED OR WAS BROKEN. OPENED A NEW SHAVER AND THE SAME ISSUE HAPPENED WITHIN 15 SECONDS. THE PROCEDURE WAS ABORTED DUE TO PROLONGED PROCEDURE TIME; MORE THAN 30 MINUTES, AND THE PATIENT ABSORBING TOO MUCH FLUID FROM THE DELAY. ADDITIONAL OPERATION WILL BE PERFORMED.

    Patient problems: Insufficient Information

    MAUDE report 20303607 ↗
  • MalfunctionSep 8, 2023Material Fragmentation; Insufficient Device Problem Information; Material Fragmentation; Insufficient Device Problem Information

    ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY, SURGEON WAS REMOVING A FIBROID IN THE UTERUS WHEN A METAL COLOR APPEARED. SURGEON HAVE NEVER SEEN THIS COLOR BEFORE. IT WAS A METAL COLOR AND NOT BLACK. IT DID NOT LEFT A METAL COLOR CONTINUOUS, AND NOT IN ALL PLACES. SURGEON COMPLETED THE PROCEDURE WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17714301 ↗
  • MalfunctionJul 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN REMOVING THE SHAVER FROM THE PACKAGING, THE PIECE THAT CLIPS INTO THE BOTTOM OF THE BLADE MUST NOT HAVE BEEN CLIPPED IN BECAUSE IT FELL OUT OF THE BLADE AND ONTO THE FLOOR. THERE WAS NO CARELESSNESS OR AGGRESSIVENESS BY THE SCRUB TECH, THE SALES REP WATCHED THE WHOLE THING HAPPEN IT JUST SIMPLY FELL OUT ONTO THE FLOOR AND WASN'T SEATED IN THE SHAVER PROPERLY. THEY GRABBED AND USED ANOTHER SHAVER TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17332002 ↗
  • InjuryApr 18, 2023Suction Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Suction Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE REPORTER, DURING HYSTEROSCOPIC RESECTION OF 2CM TYPE 1 FIBROID, THE SHAVER WAS BEING USED TO RESECT. INITIALLY THE SHAVER HAD PIERCED THE FIBROID CAPSULE, AND A GOOD AMOUNT OF TISSUE HAD BEEN RESECTED. THE SHAVER THEN APPEARED TO BE BLUNT AND WOULD NOT CUT THE TISSUE. IT ALSO APPEARED THAT THE BLADE DID NOT REACH THE SHAVER 'CAP' TO EFFECTIVELY CUT THE TISSUE. THE SURGEON USED THE SHAVER ON ENDOMETRIUM TO SEE IF THE LESS FIBROUS TISSUE WOULD BE CUT AND SUCKED INTO THE SHAVER; THIS WAS UNSUCCESSFUL. THE BLADE DID NOT APPEAR TO REACH THE TOP OF THE SHAVER CAP TO MAKE A CUT IN THE TISSUE. THE FIBROID COULD NOT BE SUCCESSFULLY COMPLETELY REMOVED. ANOTHER SHAVER WITH THE SAME LOT NUMBER WAS OPENED. AN ADDITIONAL SHAVER WAS OPENED, BUT THIS TOO WOULD NOT CUT THE FIBROID TISSUE WELL. THE PROCEDURE WAS ABORTED, FIBROID RESECTION WAS INCOMPLETE. A VIDEO WAS ATTACHED AND SHOWED THAT THE BLADE WAS NOT CUTTING THE TISSUE. AN ADDITIONAL PROCEDURE WILL BE SCHEDULED TO ATTEMPT TO RESECT THE REMAINDER OF THE FIBROID THAT WAS NOT RESECTED DURING THE PROCEDURE.

    Patient problems: Insufficient Information

    MAUDE report 16761128 ↗
  • InjuryApr 18, 2023Suction Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Suction Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE REPORTER, DURING HYSTEROSCOPIC RESECTION OF 2CM TYPE 1 FIBROID, THE SHAVER WAS BEING USED TO RESECT. INITIALLY THE SHAVER HAD PIERCED THE FIBROID CAPSULE, AND A GOOD AMOUNT OF TISSUE HAD BEEN RESECTED. THE SHAVER THEN APPEARED TO BE BLUNT AND WOULD NOT CUT THE TISSUE. IT ALSO APPEARED THAT THE BLADE DID NOT REACH THE SHAVER 'CAP' TO EFFECTIVELY CUT THE TISSUE. THE SURGEON USED THE SHAVER ON ENDOMETRIUM TO SEE IF THE LESS FIBROUS TISSUE WOULD BE CUT AND SUCKED INTO THE SHAVER; THIS WAS UNSUCCESSFUL. THE BLADE DID NOT APPEAR TO REACH THE TOP OF THE SHAVER CAP TO MAKE A CUT IN THE TISSUE. THE FIBROID COULD NOT BE SUCCESSFULLY COMPLETELY REMOVED. ANOTHER SHAVER WITH THE SAME LOT NUMBER WAS OPENED. AN ADDITIONAL SHAVER WAS OPENED, BUT THIS TOO WOULD NOT CUT THE FIBROID TISSUE WELL. THE PROCEDURE WAS ABORTED, FIBROID RESECTION WAS INCOMPLETE. A VIDEO WAS ATTACHED AND SHOWED THAT THE BLADE WAS NOT CUTTING THE TISSUE. AN ADDITIONAL PROCEDURE WILL BE SCHEDULED TO ATTEMPT TO RESECT THE REMAINDER OF THE FIBROID THAT WAS NOT RESECTED DURING THE PROCEDURE.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 16761107 ↗
  • MalfunctionMar 28, 2022Material Fragmentation; Material Fragmentation

    ACCORDING TO THE REPORTER, DURING HYSTEROSCOPIC MYOMECTOMY, THEY NOTICED WHAT LOOKED LIKE GLITTER PIECES IN THE CAVITY, SEEMED TO BE METAL COATING FROM THE SHAVER. SURGEON DECIDED TO CONTINUE BUT CHANGE OUT FOR NEW DEVICE. USED ANOTHER DENSE TISSUE SHAVER MINI. ISSUE DID NOT PROCEED WITH NEW DEVICE AND FROM WHAT DID THEY SEE WAS SHAVER SUCKED IN FRAGMENTS. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13929950 ↗
  • MalfunctionJul 20, 2021Failure to Cut; Detachment of Device or Device Component; Failure to Cut; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY PROCEDURE, THE DEVICE WOULD NOT SHAVE. THEY REPLACED THE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY. MEDTRONIC INVESTIGATION STATES THAT THERE WAS EVIDENCE THAT THE OUTER BLADE ASSEMBLY HAD BEEN BENT AT THE DISTAL END. INSPECTION OF THE INNER BLADE HAD A DEFORMATION ON THE DISTAL CUTTING EDGE. BASED ON THE EVIDENCE AVAILABLE THE REPORTED CONDITION OF COMPONENT DISENGAGED WAS CONFIRMED. COMMUNICATION INVESTIGATION STATES THAT DEVICE DID NOT DISENGAGE AND FELL INTO THE PATIENT'S CAVITY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12195944 ↗
  • MalfunctionJul 16, 2021Detachment of Device or Device Component; Intermittent Energy Output; Detachment of Device or Device Component; Intermittent Energy Output

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO DEVICE'S BLADES WORKED AT FIRST AND THEN FROZE. THE BLADES WERE REPLACED WITH ANOTHER BLADE AND THE SAME THING HAPPENED. THEY THEN SCOPED UP AND USED A DIFFERENT TYPE OF BLADE AND COMPLETED THE CASE. THERE WAS NO PATIENT INJURY. INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE UNIT HAD AN INNER BLADE FRACTURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12178874 ↗
  • InjurySep 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING AN OPERATIVE HYSTEROSCOPY, INSIDE THE UTERUS, THE DEVICE WAS LIKELY TORQUED WHICH, THEREFORE CAUSED THE BLADE TO SIGNIFICANTLY BEND AND THEN IT BROKE OFF. THE INTERNAL CUTTING BLADE BROKE OFF INSIDE THE PATIENT'S UTERUS. AN X-RAY WAS DONE. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED AND THE PROCEDURE WAS ENDED.

    Patient problems: Unintended Radiation Exposure

    MAUDE report 10538374 ↗
  • MalfunctionSep 1, 2020Material Fragmentation; Material Fragmentation

    ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY, THE DEVICE WAS IN THE UTERUS AT THE TIME OF THE ISSUE WHEREIN THE METAL FLECKS SHAVE OFF. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10477722 ↗
  • InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

    ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY MYOMECTOMY, THE DEVICE WAS FUNCTIONING PROPERLY THEN JUST STALLED AND STOPPED WORKING. THE PROCEDURE WAS ABORTED.

    Patient problems: No Code Available

    MAUDE report 10235367 ↗
  • MalfunctionApr 27, 2020Material Fragmentation; Material Fragmentation

    ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY, THE DEVICE WAS INSERTED AT THE UTERINE WALL/FUNDUS AND TISSUE RESECTION STARTED. THE DEVICE WAS WORKING PROPERLY, BUT IT APPEARED THAT UPON INITIAL RESECTION, METALLIC SHAVINGS/DUST CAME OFF THE BLADE. THE CASE WAS COMPLETED AND TISSUE WAS RESECTED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10001123 ↗
  • MalfunctionApr 1, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

    ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY, THE DEVICE WAS INSERTED AT THE UTERINE WALL OR FUNDUS AND TISSUE RESECTION STARTED. THE DEVICE WAS WORKING PROPERLY, BUT IT APPEARED THAT UPON INITIAL RESECTION, METALLIC SHAVINGS OR DUST CAME OFF THE BLADE. THE CASE WAS COMPLETED AND TISSUE WAS RESECTED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 9910004 ↗
  • MalfunctionMar 31, 2020Material Fragmentation; Connection Problem; Material Fragmentation; Connection Problem

    ACCORDING TO THE REPORTER, DURING THE MYOMECTOMY, THE SURGEON WANTED TO SWITCH TO A SOFT TISSUE SHAVER MINI BLADE AFTER USING THE DENSE TISSUE SHAVER MINI BLADE. WHEN TAKING OUT THE FIRST BLADE INSTALLED, SCRUB TECH NOTICED THERE WAS A BROKEN PIECE OF THE BLADE STUCK IN THE HANDPIECE. NOTHING FELL INTO PATIENT'S CAVITY. THE SCRUB TECH REMOVED THE BROKEN PIECE, BUT STILL WAS UNABLE TO SEAT THE NEW MINI SOFT TISSUE MINI BLADE IN THE HANDPIECE AS EVERYTIME IT WAS TRIED, IT WOULD EASILY FALL OFF OF THE HANDPIECE. THERE WAS NOTHING ELSE STUCK IN THE HAND PIECE. THE SURGEON THEN STOPPED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9902451 ↗
  • MalfunctionNov 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, THE BASE OF THE BLADE WAS DETACHED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 9358852 ↗
  • InjuryApr 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING THE HYSTEROSCOPY POLYPECTOMY / MYOMECTOMY, WHILE THE REPORTED DEVICE WAS BEING USED ON THE RESECTION OF TISSUE; THE INNER CYLINDER OF THE BLADE BROKE AND LODGED INTO THE DISTAL OUTER CYLINDER OF THE DEVICE CAUSING SHARDS OF METAL FROM THE DEVICE TO DISPERSE THROUGHOUT THE PATIENT'S UTERINE CAVITY. IT WAS UNABLE TO REMOVE ALL AMOUNTS OF METAL FROM THE PATIENT,BUT DID REMOVE THE MAJORITY. THIS LED TO EXTENDED OR TIME FOR 45 MINUTES AND ADDITIONAL TOOLS WERE NEEDED TO TRY AND INTERVENE TO REMOVE THE METAL SHARDS. X-RAY WAS NOT PERFORMED TO LOCATE THE COMPONENT OR PIECES. PATHOLOGY CAME BACK CONTAINING NO METAL AS WELL. SURGEON DESCRIBED REMNANTS OF METAL LEFT IN PATIENT AS ¿MICROSCOPIC¿. THE LOT NUMBERS PROVIDED IN THE PHOTOS.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 8482674 ↗
  • InjurySep 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY, THE DISTENTION WAS POOR WHEN THE DEVICE WAS USED. IT CAUSES POOR VISUALIZATION AND DOESN'T GIVE THE PHYSICIAN THE BEST ENVIRONMENT FOR RESECTING AND ASPIRATING TISSUE. AN EMERGENCY HYSTERECTOMY WAS PERFORMED TO STOP THE BLEEDING AND SPREAD OF POTENTIAL CANCEROUS TISSUE WITHIN THE UTERUS. THE UTERUS WAS REMOVED, THE BOWL WAS PERFORATED AND THE ILIAC ARTERY WAS COMPROMISED THAT CAUSED PERMANENT INJURY. THERE WAS ALSO A BLOOD LOSS OF 500CC THAT REQUIRES A BLOOD TRANSFUSION. THIS LENGTHEN THE PROCEDURE TO 2.5-3 HOURS. THE PATIENT WAS TRANSFERRED TO ICU FOR UNKNOWN AMOUNT OF TIME AND THE HOSPITALIZATION WAS EXTENDED.

    Patient problems: Blood Loss; Exsanguination

    MAUDE report 7882838 ↗

Other HYSTEROSCOPE (AND ACCESSORIES) devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.