n.a. 26159SHWRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04048551094471), received between Sep 6, 2023 and May 5, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Pitted

  THE FOLLOWING WAS REPORTED: "AT 09:30 ON (B)(6) 2026, THE PATIENT UNDERWENT HYSTEROSCOPIC SURGERY UNDER INTRAVENOUS ANESTHESIA. THE PLAN WAS TO USE A MICRO-SCISSOR (HYSTEROSCOPIC SCISSORS) AND A MICRO-FORCEPS (HYSTEROSCOPIC GRASPING FORCEPS) TO RESECT ENDOMETRIAL POLYPS. FOLLOWING STANDARD HYSTEROSCOPIC SURGICAL PROTOCOLS FOR FINE MANIPULATION WITH SPECIALIZED MICRO-INSTRUMENTS, PREOPERATIVE INSPECTION REVEALED SIGNIFICANT RUST ON THE SURFACES OF THE MICRO-SCISSOR AND MICRO-FORCEPS. OBVIOUS RUST STAINS WERE OBSERVED ON KEY AREAS SUCH AS THE INSTRUMENT JOINTS AND CUTTING EDGES. THE SURGEON IMMEDIATELY SWITCHED TO DIAGNOSTIC CURETTAGE TO RESECT THE POLYPS; HOWEVER, SLIGHT POLYP RESIDUE REMAINED, WHICH WAS SUBSEQUENTLY MANAGED WITH OVAL FORCEPS. THE SURGERY WAS COMPLETED SUCCESSFULLY, BUT THE PATIENT'S OPERATION TIME WAS PROLONGED. THE RUSTED INSTRUMENTS WERE RETAINED POSTOPERATIVELY AS EVIDENCE." CROSS REFERENCE MDR 9610617-2026-1009.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085220 ↗
• MalfunctionMay 5, 2026Pitted

  THE FOLLOWING WAS REPORTED: "AT 09:30 ON (B)(6) 2026, THE PATIENT UNDERWENT HYSTEROSCOPIC SURGERY UNDER INTRAVENOUS ANESTHESIA. THE PLAN WAS TO USE A MICRO-SCISSOR (HYSTEROSCOPIC SCISSORS) AND A MICRO-FORCEPS (HYSTEROSCOPIC GRASPING FORCEPS) TO RESECT ENDOMETRIAL POLYPS. FOLLOWING STANDARD HYSTEROSCOPIC SURGICAL PROTOCOLS FOR FINE MANIPULATION WITH SPECIALIZED MICRO-INSTRUMENTS, PREOPERATIVE INSPECTION REVEALED SIGNIFICANT RUST ON THE SURFACES OF THE MICRO-SCISSOR AND MICRO-FORCEPS. OBVIOUS RUST STAINS WERE OBSERVED ON KEY AREAS SUCH AS THE INSTRUMENT JOINTS AND CUTTING EDGES. THE SURGEON IMMEDIATELY SWITCHED TO DIAGNOSTIC CURETTAGE TO RESECT THE POLYPS; HOWEVER, SLIGHT POLYP RESIDUE REMAINED, WHICH WAS SUBSEQUENTLY MANAGED WITH OVAL FORCEPS. THE SURGERY WAS COMPLETED SUCCESSFULLY, BUT THE PATIENT'S OPERATION TIME WAS PROLONGED. THE RUSTED INSTRUMENTS WERE RETAINED POSTOPERATIVELY AS EVIDENCE." CROSS REFERENCE MDR 9610617-2026-1010.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084863 ↗
• MalfunctionSep 9, 2025Device Reprocessing Problem; Optical Problem; Device Reprocessing Problem; Optical Problem

  IT WAS REPORTED THAT WEAK LIGHT ON C-MAC SYSTEM USING - CHANGING TO ANOTHER WORKS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009489 ↗
• InjurySep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT WAS SCHEDULED FOR HYSTEROSCOPIC SURGERY (HSK). HOWEVER, THE PROCEDURE PROVED TO BE DIFFICULT AS IT COULD NOT BE PERFORMED WITH THE BIPOLAR RESECTOSCOPE. IT WAS THEREFORE NECESSARY TO USE HSK SCISSORS. WE HAD TWO OF THESE INSTRUMENTS IN OUR INVENTORY, AND THE SURGEON NEEDED THE SECOND HSK SCISSORS FOR ANOTHER PROCEDURE ON THE SAME DAY. THE HSK SCISSORS USED INITIALLY WORKED PERFECTLY, BUT ONE OF THE SCISSOR ARMS SUDDENLY CAME LOOSE DURING THE PROCEDURE. DESPITE AN INTENSIVE SEARCH, THE BROKEN PART COULD NO LONGER BE FOUND, EITHER IN THE IRRIGATION SYSTEM, ON THE FLOOR OR ELSEWHERE. TO BE ON THE SAFE SIDE, THE PATIENT WAS X-RAYED AND NO FOREIGN BODY WAS FOUND. AS A RESULT, THE PROCEDURE WAS DISCONTINUED. THE ORIGINAL FINDINGS WERE STILL PRESENT AND, AS THINGS STAND, THE PATIENT IS TO BE OPERATED ON AGAIN AT THE CAMPUS AT A LATER DATE. DUE TO THE FACT THAT THE PROCEDURE WAS ABORTED, THE ORIGINAL FINDINGS ARE STILL PRESENT AND THE PATIENT IS TO BE OPERATED ON AGAIN AT A LATER DATE, THE CASE IS CLASSIFIED AS REPORTABLE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE SURGURY WAS POSTPONED UNTIL (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 22983349 ↗
• InjuryAug 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NEW INFORMATION WAS PROVIDED THAT THE SURGERY DATE IS (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 22840325 ↗
• MalfunctionAug 4, 2025Mechanical Problem; Mechanical Problem

  ACCORDING TO THE INFORMATION RECEIVED JAW OF SCISSOR BROKE OFF DURING HYSTEROSCOPIC PROCEDURE FOR ADHESIOLYSIS AND POLYP REMOVAL LEAVING A PART OF THE SCISSOR BLADE IN THE PATIENTS UTERUS. THE DISLODGED PART WAS ABLE TO BE FLUSHED OUT OF THE PATIENT AND RECOVERED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709228 ↗
• MalfunctionJul 31, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  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 22680024 ↗
• MalfunctionJul 31, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SCISSORS BREAK EVEN WHEN USED ONCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE: MDR 25-1326, 25-1332, 25-1324, 25-1325, 25-1333 AND 25-1334.

  Patient problems: Insufficient Information

  MAUDE report 22680021 ↗
• MalfunctionJul 31, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  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 22680019 ↗
• MalfunctionMar 13, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DESPITE FOLLOWING THE DISINFECTION INSTRUCTIONS, THE SCISSORS IN QUESTION SHOWED OXIDATION SIGNS AND RUST FROM THE FIRST USE. DURING THE TENTH USE OF THE DEVICE IN MEDICAL PROCEDURE, ONE OF THE BRANCHES OF THE SCISSORS BROKE OFF INSIDE THE UTERINE CAVITY. THE FRAGMENT WAS RECOVERED AND EXTRACTED WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY BUT WITH A PROLONGATION OF MORE THAN 30 MINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596429 ↗
• InjuryMar 13, 2025Break; Break

  IT WAS REPORTED THAT DESPITE FOLLOWING THE DISINFECTION INSTRUCTIONS, THE SCISSORS IN QUESTION SHOWED OXIDATION SIGNS AND RUST FROM THE FIRST USE. DURING THE TENTH USE OF THE DEVICE IN MEDICAL PROCEDURE, ONE OF THE BRANCHES OF THE SCISSORS BROKE OFF INSIDE THE UTERINE CAVITY. THE FRAGMENT WAS RECOVERED AND EXTRACTED WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY BUT WITH A PROLONGATION OF MORE THAN 30 MINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596427 ↗
• InjurySep 6, 2023Corroded; Material Fragmentation; Corroded; Material Fragmentation

  IT WAS REPORTED THAT METAL FRAGMENTS AND RUST CAME OFF FROM THE INSTRUMENTS WHILE DOING A HYSTEROSCOPY AND POLYPECTOMY CASE. SOME METAL FRAGMENTS WERE RECOVERED, BUT SOME FRAGMENTS COULD BE STILL INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17691055 ↗