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

Model Number	10035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/26/2024
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 that during parturition, artificial rupture of amniotic membrane was performed using the mityhook.Upon delivery, the baby was noted to have scalp lacerations that required suturing to repair.No additional information is available.10035 mityhook 2024-10-0000502.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h6, h11.Distribution history: the distribution history cannot be traced as neither the product was returned back, nor the batch number/lot number information was provided.Manufacturing record review: a review of the device history record could not be performed because the lot number was not provided.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the complaint product lot number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Historical complaint review: a review of the 2-year complaint history showed no 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.Root cause: root cause not applicable as the complaint condition was not confirmed nor the batch number/lot number information was provided.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action in necessary, as the complaint condition was not confirmed.

• Brand Name: MITYHOOK
• Common Device Name: 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: 20566318
• Report Number: 1216677-2024-00060
• Device Sequence Number: 12719758
• Product Code: HGE
• UDI-Device Identifier: 00888937014761
• UDI-Public: (01)00888937014761
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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 Model Number: 10035
• Device Catalogue Number: 10035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown