MAUDE Adverse Event Report: COOPERSURGICAL, INC. HUMI; UTERINE MANIPULATOR

Model Number	6001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Harris-kronner uterine manipulator- injector was placed in cervix, balloon was filled with 10cc of air per instructions on package.When md was trying to position the manipulator, there was a loud snap sound, the manipulator broke inside the cervix.After the tubal ligation was completed, md went below and checked on manipulator status.Md pulled out 2 separate pieces.The manipulator had broken into two pieces.Per charge rn, pieces were collected and sent to sterile processing to be cleaned.Packaging was kept with the item.No additional information is available.1216677-2025-00019 6001 humi 2025-04-0000254.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Updated: b4, d4, g3, g6, h2, h3, h4, h6, h11.Distribution history: the complaint product was manufactured at csi on 29-oct-2024.Manufacturing record review: dhr was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc-52859 lot number m22977 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 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.A picture of the device was obtained from the customer which shows the distal end of the device separated from the handle.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.This lot number has been depleted from inventory.Root cause: the complaint condition was confirmed based on the photo provided however since the product was not returned a definitive root cause cannot be determined at this time.It should be noted that this is an isolated case.The potential root cause may be due to end user mishandling (excessive pressure applied).Coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: HUMI
• Common Device Name: UTERINE MANIPULATOR
• 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: 21891561
• Report Number: 1216677-2025-00019
• Device Sequence Number: 3530456
• Product Code: KNA
• UDI-Device Identifier: 00888937013238
• UDI-Public: (01)00888937013238(10)550005791(17)270315
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K770727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6001
• Device Catalogue Number: 6001
• Device Lot Number: 550005791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2024
• 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
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Race: White