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

Model Number	ONS1733
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: foreign: italy.H3: device discarded.Customer has stated that the product discarded and can not be returned to cooper surgical for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Patient 1/3.It was reported by the customer that while performing transvaginal collection of oocytes from the ovarian follicles, using an oocyte recovery needle, the patient experienced copious bleeding.The doctor determined that the patient sustained a hemoperitoneum of ovarian origin and repaired via operative laparoscopy.The recovery needle was discarded.No additional information is available.Ons1733 17g oocyte rcvry (b)(4).
Event or Problem Description
No additional information is available.
Additional Manufacturer Narrative
Distribution history: the complaint product was manufactured at csi on (b)(6) 2022 under work order (b)(6).Manufacturing record review: dhr was reviewed for product ons1733 and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: incoming inspection record review not applicable to this product.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions for item ons1733.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.Functional evaluation: functional evaluation not applicable to this complaint condition.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.

• Brand Name: 17G WALLACE SINGLE LUMEN OOCYTE RECOVERY SET
• Common Device Name: IVF OOCYTE ASPIRATION NEEDLE, 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: 18007464
• Report Number: 1216677-2023-00139
• Device Sequence Number: 18068080
• Product Code: MQE
• UDI-Device Identifier: 30888937021074
• UDI-Public: (01)30888937021074(10)619017570
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 619017570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female