NA M006550340Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729469773), received between Apr 5, 2024 and Apr 5, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2024Degraded; Use of Device Problem; Degraded; Use of Device Problem

  BOSTON SCIENTIFIC COMPLAINT DEPARTMENT FORWARDED A MEDWATCH REPORT, 2302300000-2024-8002, TO THE MINERVA SURGICAL COMPLAINT DEPARTMENT ON MARCH 21ST, 2024. THE MEDWATCH REPORT STATED "PATIENT PRESENTED TO THE OPERATING ROOM (OR) FOR A PLANNED DILATION AND CURETTAGE (D&C), HYDROTHERMAL ABLATION (HTA) PROCEDURE. DURING THE SURGERY, THE HTA EQUIPMENT FAILED, ALLOWING THE SCOPE TO BECOME INCREDIBLY HOT AND BURNED THIS PATIENT'S VAGINAL OPENING AND CERVIX. WE LEARNED THAT THE WOLF HYSTEROSCOPE ADAPTER WAS SUPPOSED TO BE REPLACED AT EVERY 40 USES WHICH WE DID NOT DO. WE HAVE DISCARDED ALL OF OUR SUPPLIES FROM 2005 AND HAVE ORDERED ALL NEW ONES."

  Patient problems: Burn(s)

  MAUDE report 19050595 ↗