n.a. 26159UHWRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04048551094495), received between Sep 27, 2024 and Sep 30, 2026 — classified as 10 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954117 ↗
• InjuryJun 2, 2026Break

  DURING THE CASE, THE DOCTOR GRABBED A POLLUP, AND THEY SAW SOMETHING FALL OUT A PIECE OF THE GRASPER A VERY SMALL SPEC OF A PIECE. SO THEY GRABBED ANOTHER GRASPER AND MANIPULATED LIKE THEY NORMALLY DO AND THEY ENDED UP HAVING TO GRABBED ANOTHER GRASPER TO GET THE PIECE THAT BROKE OFF. THE PATIENT WAS NOT HARMED. HOWEVER, THERE WAS A 20-MINUTE DELAY. THEY SENT THE PATIENT FOR XRAY AND DID NOT FIND ANYTHING ELSE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361798 ↗
• InjuryJun 2, 2026Break

  DURING THE CASE, THE DOCTOR GRABBED A POLLUP, AND THEY SAW SOMETHING FALL OUT A PIECE OF THE GRASPER A VERY SMALL SPEC OF A PIECE. SO THEY GRABBED ANOTHER GRASPER AND MANIPULATED LIKE THEY NORMALLY DO AND THEY ENDED UP HAVING TO GRABBED ANOTHER GRASPER TO GET THE PIECE THAT BROKE OFF. THE PATIENT WAS NOT HARMED. HOWEVER, THERE WAS A 20-MINUTE DELAY. THEY SENT THE PATIENT FOR XRAY AND DID NOT FIND ANYTHING ELSE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361790 ↗
• MalfunctionApr 27, 2026Fracture

  IT WAS REPORTED THAT DEVICE SNAPPED DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002340 ↗
• InjuryApr 13, 2026No Display/Image

  IT WAS REPORTED THAT DURING A DIAGNOSTIC HYSTEROSCOPY, A COMPONENT (BALL/JOINT) BECAME DETACHED FROM THE DISTAL TIP OF THE INSTRUMENT. THIS OCCURRED DURING NORMAL USE. THE PROCEDURE WAS ABORTED WHEN THE METAL PART OF THE INSTRUMENT WAS LOST. IT WAS SPENT THE REMAINING TIME ATTEMPTING TO LOCATE AND RETRIEVE IT. A CT SCAN OF THE ABDOMEN WAS DONE TO LOCATE THE FRAGMENT, WHICH TOOK MORE THAN 30 MINUTES - BUT WITHOUT SUCCESS. A CT SCAN IS PLANNED TO LOCATE THE BROKEN PART. THE PATIENT WAS INFORMED ABOUT THE INCIDENT AND IS FEELING ANXIOUS AND WORRIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867181 ↗
• InjuryMar 11, 2026Break

  IT WAS REPORTED THAT THE PIN FELL OUT OF GRASPERS DURING PROCEDURE AND NOW WILL NOT OPEN/CLOSE. THE PIN IS NEARLY MICROSCOPIC IN SIZE. AN ATTEMPT WAS MADE TO REMOVE THE PIN UNDER DIRECT VISUALIZATION WITH A SEPARATE GRASPER BUT WAS LOST IN THE REMOVAL PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575874 ↗
• InjuryMar 11, 2026Break

  IT WAS REPORTED THAT THE PIN FELL OUT OF GRASPERS DURING PROCEDURE AND NOW WILL NOT OPEN/CLOSE. THE PIN IS NEARLY MICROSCOPIC IN SIZE. AN ATTEMPT WAS MADE TO REMOVE THE PIN UNDER DIRECT VISUALIZATION WITH A SEPARATE GRASPER BUT WAS LOST IN THE REMOVAL PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570785 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT "RIVET BROKE ON THE DEVICE.NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553319 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT "BETTOCCHI HYSTEROSCOPE INSTRUMENT, SPECIFICALLY THE FORCEPS. THE FORCEPS WERE CONSIDERED FRAGILE AND EASILY DAMAGED, EVEN THOUGH THEY WERE RARELY USED AND STILL RELATIVELY NEW. THE FORCEPS CAN NO LONGER BE USED. THE DAMAGE IS MAINLY LOCATED AT THE TIP OF THE FORCEPS. THE HOSPITAL HAS AN ALTERNATIVE FORCEPS AVAILABLE, SO THE EXAMINATION ACTIVITIES AT THE HOSPITAL ARE NOT CURRENTLY DISRUPTED." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490414 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT SHEATH BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449420 ↗
• MalfunctionFeb 17, 2026Fracture

  IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24369341 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT THEY MADE 5 HYSTEROSCOPIES AND IT IS BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970592 ↗
• InjuryDec 4, 2025Break; Break

  IT WAS REPORTED THAT "DURING A HYSTEROSCOPY, THE FORCEPS DISINTEGRATED AFTER BEING INSERTED INTO THE SHEATH, AND A FRAGMENT OF THE FORCEPS SUBSEQUENTLY FELL INTO THE UTERINE CAVITY. OTHER FORCEPS WERE USED TO EXTRACT THE BROKEN FRAGMENT. THE USER SUGGESTS THE FORCEPS WERE DEFECTIVE. THE PROCEDURE WAS EXTENDED BY 30 MINUTES - THAT'S HOW LONG IT TOOK TO REMOVE THE RIVET". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723305 ↗
• InjuryDec 4, 2025Break; Break

  IT WAS REPORTED THAT "DURING A HYSTEROSCOPY, THE FORCEPS DISINTEGRATED AFTER BEING INSERTED INTO THE SHEATH, AND A FRAGMENT OF THE FORCEPS SUBSEQUENTLY FELL INTO THE UTERINE CAVITY. OTHER FORCEPS WERE USED TO EXTRACT THE BROKEN FRAGMENT. THE USER SUGGESTS THE FORCEPS WERE DEFECTIVE. THE PROCEDURE WAS EXTENDED BY 30 MINUTES - THAT'S HOW LONG IT TOOK TO REMOVE THE RIVET". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723304 ↗
• InjuryNov 19, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, DEVICE USED TO PERFORM AN OPERATIVE HYSTEROSCOPY WITH ENDOMETRIAL BIOPSY. THE DEVICE HAS CONTACT WITH THE PATIENT FOR APPROXIMATELY 2 MINUTES AND THE TOTAL PROCEDURE DURATION WAS APPROXIMATELY 10 MINUTES. THE PATIENT ATTENDS THE HYSTEROSCOPY CLINIC FOR FOLLOW-UP OF ENDOMETRIAL HYPERPLASIA WITHOUT ATYPIA. DURING THE PERFORMANCE OF THE HYSTEROSCOPY WITH A BETTOCCHI HYSTEROSCOPE, USING BIOPSY FORCEPS, THE FORCEPS DOES NOT CLOSE AND A SMALL METAL SCREW WAS FOUND IN THE UTERINE CAVITY (PROBABLY DETACHED FROM THE FORCEPS THAT DID NOT CLOSE). AN ATTEMPT TO RECOVER THE SCREW WITH NEW FORCEPS FAILED. AT THE END OF THE EXAMINATION, THE SCREW WAS NOT FOUND IN THE UTERINE CAVITY OR IN THE LUMBAR COLLECTION BAG. THE PATIENT WAS INFORMED OF WHAT HAD HAPPENED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23595750 ↗
• InjuryNov 19, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE INFORMATION RECEIVED, DEVICE USED TO PERFORM AN OPERATIVE HYSTEROSCOPY WITH ENDOMETRIAL BIOPSY. THE DEVICE HAS CONTACT WITH THE PATIENT FOR APPROXIMATELY 2 MINUTES AND THE TOTAL PROCEDURE DURATION WAS APPROXIMATELY 10 MINUTES. THE PATIENT ATTENDS THE HYSTEROSCOPY CLINIC FOR FOLLOW-UP OF ENDOMETRIAL HYPERPLASIA WITHOUT ATYPIA. DURING THE PERFORMANCE OF THE HYSTEROSCOPY WITH A BETTOCCHI HYSTEROSCOPE, USING BIOPSY FORCEPS, THE FORCEPS DOES NOT CLOSE AND A SMALL METAL SCREW WAS FOUND IN THE UTERINE CAVITY (PROBABLY DETACHED FROM THE FORCEPS THAT DID NOT CLOSE). AN ATTEMPT TO RECOVER THE SCREW WITH NEW FORCEPS FAILED. AT THE END OF THE EXAMINATION, THE SCREW WAS NOT FOUND IN THE UTERINE CAVITY OR IN THE LUMBAR COLLECTION BAG. THE PATIENT WAS INFORMED OF WHAT HAD HAPPENED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23595739 ↗
• MalfunctionSep 16, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE OPEN/CLOSE FUNCTION OF THE GRASPING NO LONGER WORKS. THE PIN IS MISSING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066900 ↗
• MalfunctionAug 7, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, WHEN THE CLAMP IS INSERTED INTO THE UTERUS FOR SAMPLING, A PIECE OF THE JAW OPENING MECHANISM HAS BEEN DETACHED AND LODGED INSIDE THE PATIENT. IN BOTH CASES THE FRAGMENT WAS RECOVERED, AND THE INTERVENTION WAS COMPLETED, ALTHOUGH WITH A DELAY OF LESS THAN 30 MINUTES. THE PATIENTS HAVE NOT SUFFERED ANY HARM. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741843 ↗
• MalfunctionJul 22, 2025Break; Component Missing; Detachment of Device or Device Component; Break; Component Missing; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TWO PINS OF THE JAW SYSTEM WERE MISSING, WHICH PREVENTED IT FROM OPERATING CORRECTLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565622 ↗
• MalfunctionJun 16, 2025Mechanical Problem; Mechanical Problem

  ACCORDING TO THE INFORMATION RECEIVED THE RIVET OF THE JAW IS BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216653 ↗
• MalfunctionJun 12, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED THE RIVET OF THE JAW IS BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194820 ↗
• MalfunctionJun 6, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, WHEN THE CLAMP IS INSERTED INTO THE UTERUS FOR SAMPLING, A PIECE OF THE JAW OPENING MECHANISM HAS BEEN DETACHED AND LODGED INSIDE THE PATIENT. IN BOTH CASES THE FRAGMENT WAS RECOVERED, AND THE INTERVENTION WAS COMPLETED, ALTHOUGH WITH A DELAY OF LESS THAN 30 MINUTES. FORTUNATELY, THE PATIENTS HAVE NOT SUFFERED ANY HARM. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161979 ↗
• MalfunctionMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SMALL PIN THAT HELPS THE GRASPER CLOSE ON ONE SIDE IS BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944959 ↗
• MalfunctionFeb 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT AT THE TIME OF CARRYING OUT THE PROCEDURE, THE CLAMP BROKE. BUT THERE IS CONFLICTING INFORMATION THAT INDICATES THIS HAPPENED BEFORE THE SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470505 ↗
• MalfunctionFeb 20, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE EVENT DESCRIPTION "DISTAL END: DAMAGED" THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. IT WAS REPORTED THAT THE USER USED THE NEW PLIERS DURING SURGERY, AND THE TIP OF THE PLIERS BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. IT WAS REPORTED THAT THE USER USED THE NEW PLIERS DURING SURGERY, AND THE TIP OF THE PLIERS BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426658 ↗