MAUDE Adverse Event Report: COOPERSURGICAL, INC. UTERINE MANIPULATOR TIP G; UTERINE MANIPULATOR, SINGLE-USE

Model Number	UMG670
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the metal portion of the tip came through the tip portion.No patient harm reported.No additional information available.Umg670.Uterine tip 2023-11-0000470.
Additional Manufacturer Narrative
Customer has indicated that the product is in process of being retreived from the hospital.Device will be returned to cooper surgical for investigation if released from hospital.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Distribution history: the complaint product was manufactured at csi on 29-aug-2022 under work order (b)(4) and was sold on 29-aug-2022.Manufacturing record review: dhr-324728 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: service history not applicable for this product.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: visual examination of the complaint pictures revealed that the metal rod had pierced the side of the tip through the balloon and that the metal rod appears to be bent.Per the manufacturing procedure all tips are 100% inspected and tested on the assembly line.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.There are none of this lot number left in inventory.Root cause: no definitive root cause for this issue could be reliably determined at this time.It would take a significant force to bend the metal rod.A significant force would cause the tip to be pushed towards the distal tip of the rumi.Coopersurgical will continue to monitor this complaint condition for trends.
Event or Problem Description
No additional information is available.

• Brand Name: UTERINE MANIPULATOR TIP G
• Common Device Name: UTERINE MANIPULATOR, SINGLE-USE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 18246059
• Report Number: 1216677-2023-00158
• Device Sequence Number: 12539804
• Product Code: LKF
• UDI-Device Identifier: 00888937001419
• UDI-Public: (01)00888937001419
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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 Expiration Date: 08/09/2025
• Device Model Number: UMG670
• Device Catalogue Number: UMG670
• Device Lot Number: 324728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/27/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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 Sex: Female