MAUDE Adverse Event Report: COOPERSURGICAL, INC. MITYHOOK; MITYHOOK AMNIOTOME

Model Number	10035
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Genital Bleeding (4507)
Date of Event	03/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: canada.Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
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).
Additional Manufacturer Narrative
Updated: b4, d4, g3, g6, h2, h3, h4, h6, h11.Distribution history: the complaint product was manufactured at csi on 30/oct/2020.Manufacturing record review: dhr was reviewed and no non-conformities, related to the complaint condition, were noted.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.The lot number of the product is no longer available in inventory.Root cause: root cause not applicable as the complaint condition was not confirmed.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.
Event or Problem Description
No additional information.

• Brand Name: MITYHOOK
• Common Device Name: MITYHOOK AMNIOTOME
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 1350
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611-1350 ; 4752651582
• MDR Report Key: 22125982
• Report Number: 1216677-2025-00033
• Device Sequence Number: 7421787
• Product Code: HGE
• UDI-Device Identifier: 00888937014761
• UDI-Public: (01)00888937014761(10)295044(17)231007
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2023
• Device Model Number: 10035
• Device Catalogue Number: 10035
• Device Lot Number: 295044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female