mityhook 10035Recalls & reported problems
Coopersurgical, Inc. · mityhook amniotome - a sterile amniotome to rupture the amniotic membrane · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888937014761), received between Oct 30, 2024 and Jun 2, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- Genital Bleeding1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED BY HEALTH CANADA, THAT DURING THE BIRTH, THE DOCTOR HAD DIFFICULTY HOOKING THE MEMBRANES IN ORDER TO RUPTURE THEM. COMPLAINT IS THAT THE TOOL IS POORLY DESIGNED AND PROVIDES LITTLE TACTILE FEEDBACK. THIS RESULTED IN INJURIES TO THE PATIENT RESULTING IN VAGINAL BLEEDING. 1216677-2025-00033 (B)(6) MITYHOOK (B)(4).
Patient problems: Genital Bleeding
MAUDE report 22125982 ↗InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.