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 11/23/2023

Event Type  Injury  

Manufacturer Narrative

G2: foreign: france.Customer has stated that the device was not being returned to cooper surgical for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Patient 2/2.It was reported that during an oocyte retrieval, the patient suffered a hemoperitoneum.Attempts for additional information have been made, but none has been provided.Ons1733.17g wallace oocyte rcvry 2023-11-0000656.

Event Description

No additional information is available.

Manufacturer Narrative

Distribution history the complaint product was manufactured at csi on 10-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: 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.Functional evaluation: functional evaluation not applicable to this complaint condition.Root cause : root cause not applicable as the complaint condition was not confirmed.Corrective actions: 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
• 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: 18331052
• MDR Text Key: 330545101
• Report Number: 1216677-2023-00161
• Device Sequence Number: 1
• Product Code: MQE
• UDI-Device Identifier: 30888937021074
• UDI-Public: (01)30888937021074(10)619021140(11)230110(17)280110
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K000628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 619021140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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): Other
• Patient Sex: Female