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

Model Number ONS1733

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2023

Event Type  Injury  

Event Description

Patient 2/3.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.1216677-2023-00140 ons1733 17g oocyte recovery 2023-09-0000609.

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.

Manufacturer Narrative

Distribution history the complaint product was manufactured at csi on 05-jan-2023 under work order (b)(4).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 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.

Event Description

No additional information is available.

• Brand Name: 17G WALLACE SINGLE LUMEN OOCYTE RECOVERY SET
• Type of Device: 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: 18007476
• MDR Text Key: 326556347
• Report Number: 1216677-2023-00140
• Device Sequence Number: 1
• Product Code: MQE
• UDI-Device Identifier: 20888937021077
• UDI-Public: (01)20888937021077(10)619020972
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K000628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONS1733
• Device Catalogue Number: ONS1733
• Device Lot Number: 619020972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female