n.a. 26153EARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551094167), received between Oct 17, 2018 and Jan 29, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2025Break; Break

  IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2024, THE PHYSICIAN WAS TRYING TO GET THE PRODUCT THROUGH THE CERVIX AND THE SCOPE BROKE. THE HYSTEROSCOPE SHEATH AND HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM WERE ATTACHED (BOTH INSTRUMENTS WERE BEING USED DURING THE PROCEDURE).IT WAS REPORTED DURING THE HYTERSOCOPY PROCEDURE WAS PROLONGED FOR 30 MINUTES ON (B)(6) 2024, THE SURGEON WAS NOT ABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS REFERRED TO GYN CROSS REFERENCE MDR: 9610617-2025-00026.

  Patient problems: Insufficient Information

  MAUDE report 21270385 ↗
• MalfunctionJan 14, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2024, THE PHYSICAN WAS TRYING TO GET THEPRODUCT THROUGH THE CERVIX AND THE SCOPE BROKE. THE HYSTEROSCOPE SHEATH AND HOPKINS TELESCOPE 30°, 2.9 MM, 30 CM WERE ATTACHED (BOTH INSTRUMENTS WERE BEING USED DURING THE PROCEDURE). IT WAS NOT REPORTED IF THERE WAS ANY HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER MULTIPLE ATTEMPTS. CROSS REFERENCE MDR: 9610617-2025-00026.

  Patient problems: Insufficient Information

  MAUDE report 21150664 ↗
• InjuryOct 4, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SURGEON OBSERVED DEBRIS POSSIBLY COMING FROM THE SHEATH. IT WAS AN APPEARANCE OF METALLIC FLAKES IS WAS SMALL ENOUGH THAT IT COULD NOT BE SEEN BY THE NAKED EYE ONLY THROUGH THE SCOPE AND CAMERA.

  Patient problems: Foreign Body In Patient

  MAUDE report 17873605 ↗
• InjuryOct 4, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SURGEON OBSERVED DEBRIS POSSIBLY COMING FROM THE SHEATH. IT WAS AN APPEARANCE OF METALLIC FLAKES IS WAS SMALL ENOUGH THAT IT COULD NOT BE SEEN BY THE NAKED EYE ONLY THROUGH THE SCOPE AND CAMERA.

  Patient problems: Foreign Body In Patient

  MAUDE report 17873511 ↗
• MalfunctionOct 17, 2018Device Contamination with Chemical or Other Material

  ALLEGEDLY, DURING A HYSTEROSCOPY PROCEDURE, THE HOSPITAL REPORTED THEY SAW TISSUE FROM A PREVIOUS CASE COME OUT OF THE INSTRUMENT CHANNEL OF THE SHEATH WHEN AN INSTRUMENT WAS PUT THROUGH THE CHANNEL.

  Patient problems: No Information

  MAUDE report 7976394 ↗