MAUDE Adverse Event Report: COOPERSURGICAL, INC. 17G WALLACE SINGLE LUMEN OOCYTE RECOVERY SET; IVF OOCYTE ASPIRATION NEEDLE

Model Number	ONS1733
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Perforation (2001); Intermenstrual Bleeding (2665)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: france.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 oocyte recovery on (b)(6) 2025, the patient suffered a hemoperitoneum and a hemorrhagic vaginal bleed.No additional information available.Ons1733, 17g wallace oocyte, 2025-04-0000565.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h4, h6, h11.Distribution history: the complaint product was manufactured at csi on november 17th, 2023.A total of (b)(4) units (1250 shelf-boxes) were manufactured for this lot.Manufacturing record review: dhr was reviewed and no non-conformities related to the complaint condition were noted.Incoming inspection review: all raw materials used to perform the work order were reviewed, all components passed iqc inspection accordingly and no issues were found for the raw materials.Historical complaint review: a review of the 2-year complaint history was performed, 22 complaints were reported to have experienced hemoperitoneum using the ons1733, however none were confirmed.Also note: 20 complaints were generated from one report from a single facility.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: visual evaluation of the complaint product could not be completed as the complaint product will not be returned to coopersurgical.If the product should be returned later, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: functional evaluation of the complaint product could not be completed as the complaint product will not be returned to coopersurgical.If the product should be returned later, it will be evaluated, and any findings will be appended to this investigation.Root cause: root cause analysis cannot be performed since units did not return and complaint cannot be confirmed, however if the product is returned, an amendment will be attached to this investigation accordingly.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

• Brand Name: 17G WALLACE SINGLE LUMEN OOCYTE RECOVERY SET
• Common Device Name: IVF OOCYTE ASPIRATION NEEDLE
• 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: 21987121
• Report Number: 1216677-2025-00025
• Device Sequence Number: 4618466
• Product Code: MQE
• UDI-Device Identifier: 00888937021073
• UDI-Public: (01)00888937021073(10)619033044
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K000628
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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: ONS1733
• Device Catalogue Number: ONS1733
• Device Lot Number: 619033044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• 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: Female