n.a. 26159BHWRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04048551094242), received between Oct 11, 2024 and Aug 27, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Material Separation

  The following was reported: During hysteroscopic surgery in the Department of Gynecology, forceps model 26159BHW were used for the procedure. The forceps functioned properly for the first several uses, but failed to open upon subsequent use. The forceps were removed from the uterine cavity for examination, and the jaw screw ofthe forceps was found missing. The physician suspected that the fallen screw might remain inside the patient's body; therefore, hysteroscopic exploration was performed, yet the missing screw was not located. Nevertheless, the physician considered there remained a risk that the screw could be retained within the uterine cavity, hence thisreport was submitted.

  Patient problems: Foreign Body In Patient

  MAUDE report 50487502 ↗
• InjuryAug 27, 2026Material Separation

  The following was reported: During hysteroscopic surgery in the Department of Gynecology, forceps model 26159BHW were used for the procedure. The forceps functioned properly for the first several uses, but failed to open upon subsequent use. The forceps were removed from the uterine cavity for examination, and the jaw screw ofthe forceps was found missing. The physician suspected that the fallen screw might remain inside the patient's body; therefore, hysteroscopic exploration was performed, yet the missing screw was not located. Nevertheless, the physician considered there remained a risk that the screw could be retained within the uterine cavity, hence thisreport was submitted.

  Patient problems: Foreign Body In Patient

  MAUDE report 50487493 ↗
• InjuryJun 22, 2026Material Fragmentation

  IT WAS REPORTED THAT WHILE IN THE UTERINE CAVITY, THE HINGE SCREW OF THE BIOPSY FORCEPS CAME LOOSE. COULD NOT FIND THE SCREW (VERY MINUSCULE).

  Patient problems: Foreign Body In Patient

  MAUDE report 25585507 ↗
• MalfunctionMar 5, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524050 ↗
• MalfunctionFeb 10, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL TIP FALL OFF, ALWAYS. DURING THE TECHNICAL INSPECTION IT WAS DETERMINED THAT THE PIN FROM THE DISTAL JOINT IS MISSING. THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21345398 ↗
• MalfunctionNov 8, 2024Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY PROCEDURE IN THE OBSTETRICS AND GYNECOLOGY DEPARTMENT, AN ISSUE OCCURRED WHILE USING THE DEVICE TO COLLECT TISSUE SAMPLES FROM A LESION. THE CONNECTING PART OF THE JAW EXPERIENCED A FAILURE, CAUSING THE PIN TO DETACH. AS A RESULT, THERE WAS A ROUGHLY ONE-HOUR PROCESS TO LOCATE THE PIN WITHIN THE PATIENT'S BODY, AND IT WAS SUCCESSFULLY RETRIEVED. IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. SINCE THE PROCEDURE HAD TO BE PROLONGED BY ROUGHLY ONE-HOUR TO LOCATE THE PIN WITHIN THE PATIENT'S BODY, THIS CASE IS DEEMED REPORTABLE AS A PRECAUTIONARY ACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642574 ↗
• MalfunctionOct 30, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING GYNECOLOGIC HYSTEROSCOPIC SURGERY, THE CONNECTION PART OF THE JAW BROKE WHILE THE PRODUCT WAS BEING USED AS A HYSTERO SHEATH WORKING CHANNEL TO COLLECT A LESION. THE HOSPITAL STAFF DO NOT KNOW WHERE THE MISSING PART HAS FALLEN OR IF X-RAYS WERE TAKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569731 ↗
• MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  "IT WAS REPORTED THAT DURING GYNECOLOGIC HYSTEROSCOPIC SURGERY, THE CONNECTION PART OF THE JAW PART FAILED WHEN THE PRODUCT WAS USED AS HYSTERO SHEATH WORKING CHANNEL TO COLLECT LESIONS. THE SURGERY WAS PROLONGED FOR LESS THAN 15 MINUTES. AFTER THE SURGERY THE PRODUCT WAS RETURNED TO THE LOCAL SUBSIDIARY AND INSPECTED. IT WAS DISCOVERED THAT A BAR-LIKE PART CONNECTING TWO SECTIONS OF THE SQUARE BOX WAS MISSING. NO HARM ON PATIENT OR NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. BECAUSE OF THE UNCERTAIN INFORMATION IF THE FALLEN OFF CONNECTION PART WAS LEFT IN THE PATIENT A REPORT TO THE FDA IS REQUIRED AS A PRECAUTIONARY MEASURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20429794 ↗