TruClear 72203012Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884521744110), received between Apr 30, 2018 and Aug 12, 2026 — classified as 15 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Detachment of Device or Device Component; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222303 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT DURING A MYOMECTOMY VIA HYSTEROSCOPY, THE BLADE TIP OF THE SHAVER PLUS BROKE DURING THE REMOVAL STEP. THE ISSUE WAS RESOLVED BY OPENING A SECOND BLADE, AND NO ADDITIONAL OPERATION WAS REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578815 ↗
• MalfunctionFeb 3, 2026Failure to Cut; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY POLYPECTOMY THE SOFT TISSUE SHAVER WAS NOT DISSECTING PROPERLY, APPEARED SLOW, AND SEEMED BLUNT. THE DENSE TISSUE SHAVER PLUS WAS THEN USED, BUT THE SITUATION DID NOT IMPROVE. A REUSABLE HAND INSTRUMENT WAS ALSO TRIED, RESULTING IN ONLY A VERY SLIGHT IMPROVEMENT. THE POLYP BEING REMOVED WAS OVER 3 CM IN SIZE. DUE TO THE PERFORMANCE OF THE DEVICES, THE PROCEDURE HAD TO BE COMPLETED USING BIPOLAR RESECTION, WHICH WAS NOT INITIALLY AVAILABLE IN THE HOSPITAL. THIS SWITCH EXTENDED THE SURGICAL TIME BY ONE HOUR.

  Patient problems: Insufficient Information

  MAUDE report 24244715 ↗
• InjuryDec 17, 2025Material Fragmentation; Intermittent Energy Output; Material Fragmentation; Intermittent Energy Output

  IT WAS REPORTED THAT DURING THE MIDDLE OF A HYSTEROSCOPY MYOMECTOMY PROCEDURE, THE SHAVER HANDPIECE STOPPED WORKING WHILE BEING APPLIED TO THE UTERINE WALL. THE HANDPIECE WAS UNPLUGGED AND REPLUGGED, AFTER WHICH IT RESUMED FUNCTIONING, BUT A HUMMING NOISE WAS HEARD. THE BLADE DISCHARGED METAL SHARDS INTO THE CAVITY, AND REMINISCENCE OF GLITTER PARTICLES (METAL FRAGMENTS) REMAINED AFTER RESECTION. THE METAL FRAGMENTS WERE NOT REMOVED OR RETRIEVED AFTER THE CASE. THE SURGEON STATED THAT IT WAS OKAY TO LEAVE THEM INSIDE CAVITY. NO X-RAY WAS PERFORMED TO LOCATE OR CONFIRM ALL PIECES OF THE COMPONENT. THE FOREIGN TISSUE WAS COMPLETELY RESECTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23825992 ↗
• MalfunctionNov 13, 2025Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; Suction Failure; Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; Suction Failure

  IT WAS REPORTED THAT DURING A HYSTEROSCOPIC MYOMECTOMY, THE SHAVER EXPERIENCED SEVERAL ISSUES DURING THE REMOVAL STEP. THE DEVICE BLADE JAMMED DUE TO AN OVERBITE, AND THE WINDOW LOCK WAS NOT ADEQUATE FOR VISUALIZATION. ADDITIONALLY, SUCTION TO THE TIP PERSISTED WHEN THE DEVICE WAS NOT WINDOW LOCKED. THE DEVICE WAS REPLACED WITH ONE FROM A DIFFERENT LOT TO COMPLETE THE CASE. THERE WAS UNANTICIPATED TISSUE LOSS.

  Patient problems: Tissue Breakdown

  MAUDE report 23544549 ↗
• InjuryNov 11, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PROCEDURE, ONE BLADE EXHIBITED EXCESSIVE LEAKAGE WHILE BEING WINDOW LOCKED, COMPROMISING VISUALIZATION AND INCREASING FLUID USAGE. ADDITIONALLY, ANOTHER BLADE DID NOT COME WINDOW LOCKED AS EXPECTED, REQUIRING A MANUAL WINDOW-LOCKING PROCEDURE AND ADDING COMPLEXITY TO THE SURGERY. THERE WAS NO PATIENT INVOLVED.

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

  MAUDE report 23520319 ↗
• InjuryNov 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 AFTER PROCEDURE ONE BLADE EXHIBITED EXCESSIVE LEAKAGE WHILE BEING WINDOW LOCKED, COMPROMISING VISUALIZATION AND INCREASING FLUID USAGE. ADDITIONALLY, ANOTHER BLADE DID NOT COME WINDOW LOCKED AS EXPECTED, REQUIRING A MANUAL WINDOW-LOCKING PROCEDURE AND ADDING COMPLEXITY TO THE SURGERY. THERE WAS NO PATIENT INVOLVED.

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

  MAUDE report 23520289 ↗
• MalfunctionJul 10, 2025Material Opacification; Adverse Event Without Identified Device or Use Problem; Material Opacification; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DILATION AND CURETTAGE (D<(>&<)>C) HYSTEROSCOPY AND MYOMECTOMY PROCEDURE, PRIOR TO RESECTION, AS SOON AS THE SHAVER WAS INSERTED, THE SUCTION WAS CONTINUOUSLY ON, CAUSING ADDITIONAL BLEEDING AND LOSS OF VISUALIZATION IN THE CAVITY, WHICH EXTENDED THE SURGICAL TIME BY 30 MINUTES. THERE WAS NO BLOOD TRANSFUSION AND NO REOPERATION DONE TO THE PATIENT TO STOP THE BLEEDING. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THE ISSUE WAS ISOLATED TO THE BLADE, AND THE SCOPE WORKED PROPERLY UNTIL THE BLADE WAS INSERTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22468982 ↗
• InjuryJun 18, 2025Material Opacification; Adverse Event Without Identified Device or Use Problem; Material Opacification; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DILATION AND CURETTAGE HYSTEROSCOPY AND MYOMECTOMY PROCEDURE, PRIOR TO RESECTION, THE USE OF THE SHAVER RESULTED IN A LOSS OF VISUALIZATION, WHICH EXTENDED THE SURGICAL TIME BY 30 MINUTES. A NEW BLADE WAS OBTAINED BUT HAD THE SAME ISSUE. AN ADDITIONAL OPERATION WAS REQUIRED TO CORRECT THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 22283847 ↗
• InjuryJun 18, 2025Material Opacification; Adverse Event Without Identified Device or Use Problem; Material Opacification; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DILATION AND CURETTAGE (D/C) HYSTEROSCOPY AND MYOMECTOMY PROCEDURE, PRIOR TO RESECTION, THE USE OF THE SHAVER RESULTED IN A LOSS OF VISUALIZATION, WHICH EXTENDED THE SURGICAL TIME BY 30 MINUTES. A NEW BLADE WAS OBTAINED BUT HAD THE SAME ISSUE. AN ADDITIONAL OPERATION WAS REQUIRED TO CORRECT THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 22283800 ↗
• MalfunctionMar 3, 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 HYSTEROSCOPY AND MYOMECTOMY PROCEDURE, THE DENSE TIS SHAVER PLUS EXPERIENCED A FAILURE OF THE WINDOW LOCK FEATURE AFTER INSERTING THE BLADE INTO THE BACK OF THE SCOPE WHEN IN THE UTERUS. THIS ISSUE LED TO UNANTICIPATED TISSUE LOSS. THE BLADE DID NOT COME PRE-WINDOW LOCKED, AND ATTEMPTS TO LOCK IT WITH THE FOOT PEDAL WERE UNSUCCESSFUL AS IT WOULD FALL OUT OF WINDOW LOCK DURING RESECTION. THERE WAS NO ISSUE WITH HANDPIECE. TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE, SUCTION WAS MANUALLY TURNED ON AND OFF TO ENSURE IT WAS ONLY ACTIVE DURING RESECTION. NO ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 21503995 ↗
• InjuryApr 30, 2024Suction Problem; Adverse Event Without Identified Device or Use Problem; Suction Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING POST OPERATIVE HYSTEROSCOPIC MYOMECTOMY, NO PRODUCT FAILURE/ISSUES AND THERE WERE NO ISSUES WITH THE HYSTEROLUX. FLUID DEFICIT READING INCREASED QUICKLY THROUGHOUT THE PROCEDURE. ONCE DEFICIT LIMIT WAS REACHED, AN ABDOMINAL ULTRASOUND SHOWED FREE FLUID INSIDE PATIENT¿S ABDOMEN. FINAL FLUID DEFICIT WAS RECORDED AT 2520 CC OF NS. MANUAL COUNT WAS ALSO PERFORMED TO CONFIRM CORRECT FLUID SYSTEM READING. FLUID WAS SUCTIONED OFF FLOOR IN THE AMOUNT OF ~280CC. PATIENT DEVELOPED PULMONARY EDEMA INTO POST ANESTHESIA CARE UNIT. BILEVEL POSITIVE AIRWAY PRESSURE WAS PERFORMED AND ADMINISTRATION OF FUROSEMIDE. THE ENTIRE HYSTEROSCOPY WAS APPROXIMATELY 10 MINUTES. PATIENT WAS SAID TO BE STABLE A FEW HOURS LATER. THE EVENT LEAD THE PATIENT TO STAY OVERNIGHT IN THE HOSPITAL AND WAS DISCHARGED THE NEXT DAY.

  Patient problems: Pulmonary Edema

  MAUDE report 19214943 ↗
• InjuryJul 19, 2023Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY MYOMECTOMY, THE HANDPIECE AND BLADE JUST STOPPED WORKING AND CONTROL UNIT SAID "STA LLED MOTOR, TRY NEW HANDPIECE". THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. HAND TO SWITCH OUT HANDPIECES AND BLADES AND CASE WAS ABORTED AFTER TWO BLADES AND TWO HANDPIECES WERE ATTEMPTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356472 ↗
• InjuryJul 19, 2023Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY MYOMECTOMY, THE HANDPIECE AND BLADE JUST STOPPED WORKING AND CONTROL UNIT SAID "STA LLED MOTOR, TRY NEW HANDPIECE". THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. HAND TO SWITCH OUT HANDPIECES AND BLADES AND CASE WAS ABORTED AFTER TWO BLADES AND TWO HANDPIECES WERE ATTEMPTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356298 ↗
• MalfunctionJul 11, 2023Material Fragmentation; Material Fragmentation

  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 17300320 ↗
• MalfunctionMar 2, 2023Suction Problem; Adverse Event Without Identified Device or Use Problem; Suction Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING MYOMECTOMY, INSIDE OF THE UTERINE CAVITY, THE UTERINE CAVITY COULD NOT BE DISTENDED. EACH TIME THE SURGEON WENT TO ACTIVATE THE BLADE, IT WOULD LOSE VISUALIZATION DUE TO THE LOSS OF SUCTION AT THE TIP OF THE BLADE. THE BLADE WAS WINDOW-LOCKED, BUT WAS STILL LEAKING SUCTION FROM THE DISTAL TIP. TO COMPLETE THE PROCEDURE ANOTHER DEVICE WAS USED. THE SURGEON WOULD ONLY LOSE DISTENSION IN THE CAVITY WHEN THE BLADE WAS INSERTED AND TURNED ON THE SUCTION LEVER TO THE HANDPIECE SHAVER. THE BLADE IS SUPPOSED TO ¿WINDOW LOCK¿ WHEN THE BLACK LINE IN THE INTERNAL CANNULA IS LINED UP WITHIN THE BLACK ¿V¿ OF THE EXTERNAL CANNULA. WHEN THE DEVICE WAS REMOVED , THE SUCTION WAS LEAKING, AND THEREFORE KNEW IT WAS NOT WINDOW LOCKING CORRECTLY. TWO DIFFERENT BLADESWERE TRIED FROM THE SAME LOT NUMBER AND BOTH BLADES WERE CREATING THE SAME ISSUE. THERE WAS 1.5 HOURS EXTENDED TIME. 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 16469131 ↗
• MalfunctionMar 2, 2023Suction Problem; Adverse Event Without Identified Device or Use Problem; Suction Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING MYOMECTOMY, INSIDE OF THE UTERINE CAVITY, THE UTERINE CAVITY COULD NOT BE DISTENDED. EACH TIME THE SURGEON WENT TO ACTIVATE THE BLADE, IT WOULD LOSE VISUALIZATION DUE TO THE LOSS OF SUCTION AT THE TIP OF THE BLADE. THE BLADE WAS WINDOW-LOCKED, BUT WAS STILL LEAKING SUCTION FROM THE DISTAL TIP. TO COMPLETE THE PROCEDURE ANOTHER DEVICE WAS USED. THE SURGEON WOULD ONLY LOSE DISTENSION IN THE CAVITY WHEN THE BLADE WAS INSERTED AND TURNED ON THE SUCTION LEVER TO THE HANDPIECE SHAVER. THE BLADE IS SUPPOSED TO ¿WINDOW LOCK¿ WHEN THE BLACK LINE IN THE INTERNAL CANNULA IS LINED UP WITHIN THE BLACK ¿V¿ OF THE EXTERNAL CANNULA. WHEN THE DEVICE WAS REMOVED, THE SUCTION WAS LEAKING, AND THEREFORE KNEW IT WAS NOT WINDOW LOCKING CORRECTLY. TWO DIFFERENT BLADES WERE TRIED FROM THE SAME LOT NUMBER AND BOTH BLADES WERE CREATING THE SAME ISSUE. THERE WAS 1.5 HOURS EXTENDED TIME. 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 16467249 ↗
• InjuryJun 24, 2022Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE INSIDE THE UTERINE CAVITY PRIOR TO MYOMECTOMY, THEY WENT TO PERFORM WINDOW LOCK, BUT DID NOT FUNCTION. THE DEVICE WAS THEN REMOVED FROM THE UTERINE CAVITY AND FURTHER COMPLICATIONS IN RELATION TO DEVICES NOT WORKING WERE EXPERIENCED. THEY HAVE TESTED ONE HANDPIECE AND IT WAS RUNNING EXCEEDINGLY FAST, SO FAST THAT IT SEIZES THE TEST BLADE. IT RAN AT 3500 RPM THEN STOPPED. THEY'VE TRIED A SECOND HANDPIECE AND AGAIN IT WAS RUNNING AT SPEEDS IN EXCESS OF WHAT IS DISPLAYED ON THE CONTROL UNIT, ABOUT 1000 RPM OVER. THEY CHANGED HANDPIECE AND BLADE AND EXPERIENCED THE SAME ISSUE. THEY WERE USING A DENSE TISSUE SHAVER PLUS. IT WAS NOTED THAT THE DENSE TISSUE SHAVER PLUS DEVICE JAMMED ON ALL HANDPIECES WHEN THE DEVICE HAD BEEN RUNNING FOR OVER 1MIN AT 2500 RPM. THE CASE WAS CANCELLED. THEY WERE UNABLE TO TREAT THE PATIENT AND WAS RESCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14801209 ↗
• InjuryFeb 22, 2022Fail-Safe Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Fail-Safe Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING AN OPERATIVE HYSTEROSCOPY, HYSTEROSCOPIC MYOMECTOMY PROCEDURE, THE BLADE OF THE DEVICE WOULD NOT MOVE WHEN WINDOW LOCK PRESSED ON FOOTSWITCH. WINDOW LOCK DID NOT FUNCTION AND TEST BLADE RAN AT EXCEEDINGLY FAST SPEEDS. THE PATIENT WAS UNABLE TO BE TREATED AND WAS RESCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13578502 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE START OF THE PROCEDURE, WHEN RUNNING A DENSE TISSUE SHAVER PLUS DEVICE ON THE HANDPIECE WITH A SCOPE AND A TISSUE SHAVER, IT JAMMED AND FAILED TO ROTATE. SWITCHED HANDPIECES AND BLADES AND AGAIN EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS CANCELLED, THEN RESCHEDULED AND COMPLETED USING ANOTHER EQUIPMENT. PATIENT WAS UNDER ANAESTHESIA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13489400 ↗
• MalfunctionSep 10, 2021Break; Detachment of Device or Device Component; Positioning Problem; Break; Detachment of Device or Device Component; Positioning Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE DEVICE WAS BEING INSERTED INTO THE HAND-PIECE IT WOULD NOT LOCK INTO PLACE AND THE SIDE TAB WHICH LOCKS INTO PLACE BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12452841 ↗
• MalfunctionAug 17, 2021Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY MYOMECTOMY, A PIECE OF THE BLADE BROKE OFF AND BECAME DISLODGED INTO THE PATIENTS FIBROID. ONE LARGE PIECE OF METAL AND SEVERAL TINY SHARDS OF METAL WERE SEEN LODGED IN THE FIBROID FROM WHERE THE METAL PIECE BROKE. IT WAS REMOVED FROM CAVITY BY GRASPERS AND BY USING ANOTHER DENSE TISSUE SHAVER PLUS TO CONTINUE RESECTING THE FIBROID WHERE TINY SHARDS OF METAL MAY HAVE GOTTEN STUCK. THE PHOTO ATTACHED SHOWS THE PIECE OF THE BLADE. THE PATIENT HAS NOT HAD AN X-RAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333232 ↗
• MalfunctionJun 17, 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 WITH MYOMECTOMY PROCEDURE, THE DEVICE WOULD NOT RESECT. WHEN THE FOOT PEDAL WAS PRESSED THE BLADE WOULD NOT ACTIVATE OR MOVE. A NEW DEVICE WAS PULLED FOR USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12018478 ↗
• MalfunctionMay 14, 2021Material Protrusion/Extrusion; Intermittent Energy Output; Material Protrusion/Extrusion; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING MIDDLE OF THE HYSTEROSCOPY, THE SCOPE WITH BLADE WAS IN THE UTERUS AND THE BLADE JUST STOPPED WORKING. REPLACED WITH ANOTHER BLADE AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY. THREE PHOTOGRAPHS WERE RECEIVED AND SHOWED THAT THE SHAVER BLADE TIP WAS CLOSED AND THERE WERE SOME SHARP EDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826901 ↗
• MalfunctionMar 29, 2021Detachment of Device or Device Component; Mechanical Jam; Noise, Audible; Detachment of Device or Device Component; Mechanical Jam; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A DIAGNOSTIC HYSTEROSCOPY PROCEDURE, THE DEVICE WAS NONFUNCTIONAL IN ACTIVATING OR IT STOPPED ROTATING. THE DEVICE WAS MAKING AN UNUSUAL NOISE. THE PROCEDURE WAS EXTENDED FOR 5 MINUTES. A NEW DEVICE WAS OPENED AND USED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. MEDTRONIC INVESTIGATION STATE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582213 ↗