n.a. 26159EHWRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04048551094280), received between Aug 9, 2023 and Sep 30, 2026 — classified as 6 injuries, 8 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 14 most recent of 14 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 50954111 ↗
• MalfunctionSep 30, 2026Fracture

  It was reported that "Scissors tip fractured without detachment during surgery and required replacement." No negative impact in state of health reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942283 ↗
• MalfunctionApr 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CUSTOMER'S SCISSORS BROKE DURING THE OPERATION. THE PATIENT WAS NOT PUT AT RISK, AND NO NEGATIVE IMPACT ON THE PATIENT'S HEALTH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801818 ↗
• MalfunctionJul 31, 2025Break; Detachment of Device or Device Component; Break

  IT WAS REPORTED THAT THE SCISSORS BREAK EVEN WHEN USED ONCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE: MDR 25-1326, 25-1331, 25-1325, 25-1324 AND 25-1333.

  Patient problems: Insufficient Information

  MAUDE report 22680459 ↗
• MalfunctionJul 31, 2025Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT THE SCISSORS BREAK EVEN WHEN USED ONCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 22680031 ↗
• MalfunctionJul 31, 2025Break; Detachment of Device or Device Component; Break

  IT WAS REPORTED THAT THE SCISSORS BREAK EVEN WHEN USED ONCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 22680026 ↗
• MalfunctionJul 31, 2025Break; Detachment of Device or Device Component; Break

  IT WAS REPORTED THAT THE SCISSORS BREAK EVEN WHEN USED ONCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE: MDR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 22680025 ↗
• MalfunctionApr 3, 2025Break; Material Fragmentation; Detachment of Device or Device Component; Break; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PIECE BROKE OFF IN PATIENT WHILE PERFORMING A HYSTEROSCOPY, WERE ABLE TO RETRIEVE THE BROKEN PIECE WITHOUT HARM TO THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766321 ↗
• InjuryMar 26, 2025Break; Break

  IT WAS REPORTED THAT "THE DOCTOR WAS NOT ABLE TO EXCISE THE FULL LESION IN THE CERVIX BECAUSE OF THE BREAKAGE OF THE INSTRUMENT. THIS LED HER TO REVERT TO A D AND C (DILATION AND CURETTAGE) SO THAT THE LESION COULD BE EXCISED COMPLETELY. PROLONGATION OF SURGERY WAS 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED".

  Patient problems: Insufficient Information

  MAUDE report 21698761 ↗
• InjuryMar 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT "THE DOCTOR WAS NOT ABLE TO EXCISE THE FULL LESION IN THE CERVIX BECAUSE OF THE BREAKAGE OF THE INSTRUMENT. THIS LED HER TO REVERT TO A D AND C (DILATION AND CURETTAGE) SO THAT THE LESION COULD BE EXCISED COMPLETELY. PROLONGATION OF SURGERY WAS 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED".

  Patient problems: Insufficient Information

  MAUDE report 21698754 ↗
• InjurySep 26, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PROCEDURE WAS INCOMPLETE BECAUSE IT WAS NOT POSSIBLE TO COLLECT MATERIAL FOR BIOPSY, A NEW DATE HAS BEEN SCHEDULED FOR THE PROCEDURE. SINCE THE NEW PROCEDURE HAVE TO BE SCHEDULED, THIS CASE IS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20315466 ↗
• InjurySep 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PROCEDURE WAS INCOMPLETE BECAUSE IT WAS NOT POSSIBLE TO COLLECT MATERIAL FOR BIOPSY, A NEW DATE HAS BEEN SCHEDULED FOR THE PROCEDURE. SINCE THE NEW PROCEDURE HAVE TO BE SCHEDULED, THIS CASE IS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20314963 ↗
• InjuryAug 9, 2023Crack; Material Fragmentation; Use of Device Problem; Crack; Material Fragmentation; Use of Device Problem

  TINY METAL FRAGMENTS (POWDER-LIKE) WERE DISLODGED FROM THE SCISSORS WHEN IT WAS INSERTED INTO THE PATIENT'S UTERUS VIA SINGLE-FLOW OPERATING SHEATH. ONE LARGER FRAGMENT ATTEMPTED TO BE REMOVED BUT WASHED OUT WHEN TRYING TO TRANSFER TO THE SPECIMEN CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491417 ↗
• InjuryAug 9, 2023Crack; Material Fragmentation; Crack; Material Fragmentation

  TINY METAL FRAGMENTS (POWDER-LIKE) WERE DISLODGED FROM THE SCISSORS WHEN IT WAS INSERTED INTO THE PATIENT'S UTERUS VIA SINGLE-FLOW OPERATING SHEATH. ONE LARGER FRAGMENT ATTEMPTED TO BE REMOVED BUT WASHED OUT WHEN TRYING TO TRANSFER TO THE SPECIMEN CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491414 ↗