MAUDE Adverse Event Report: COOPERSURGICAL, INC. 17G WALLACE OOCYTE RCVRY

Model Number ONS1733

Device Problem Defective Component (2292)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Report stated "1.Found the tip of the single lumen needle was blunt, and failed for puncture while processing, and the whole procedure was observed by the president of the hospital.So that our customer want to figure out the source of the problem." any patient injury or impact to the gamete or embryo? yes-the patient's surgery was influenced by the problematic needle, and exchange during the procedure.Was a medical or procedural intervention required? no.Aug 25, 2022- follow-up stated : what is the extent of patient injury as a result of reported condition? a: patient certainly got injury due to needle exchange.Please explain how the reported condition impacted the surgery.A: physician process in regular way, so if met the situation of aspiration problem; leakage or blunted needle tip, the physician won't continuous the process but exchange to a new needle for complete the procedure.What procedure was the physician performing? a: oocyte recovery.Did the physician perform any extra step to complete the procedure/how did physician complete the procedure? a: just exchange to a new needle for process.Was there any significant delay as result of the reported condition? 30 minutes? a: no.Additionally " 1.Patient with excessive blood loss and extra painful due to needle (ons1733) exchange, because have to pull out the problematic one and change to the new one for instead, which leaded to the second damage.Except that all the procedure just follow the general standards and guidelines.17g wallace oocyte rcvry ons1733 e-complaint-2022-08-0000151.

Manufacturer Narrative

Investigation no sample returned review dhr *analysis and findings distribution history the complaint product was manufactured at csi on (b)(6) 2021 under work order 5986.Manufacturing record review dhr was reviewed, and no events related to the complaint condition reported under this complaint was detected.The dhr can be found in mastercontrol under the infocard title cr_dhr_ons1733_5986 incoming inspection review all raw material used to perform the work order 5986 was reviewed, all components achieve with the quality requirements to be used.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history was reviewed, 139 complaints were reported under the ons1733, 20 complaints were reported with similar condition "needle bend".Product receipt units returned under this complaint number is not available.Visual evaluation visual evaluation of the complaint product was not completed, units returned under this complaint number is not available.Functional evaluation functional evaluation of the complaint product was not completed, units returned under this complaint number is not available.Root cause root cause can be determinate due samples are not available, complaint condition is not capable to confirm.However, coopersurgical has the controls implemented to avoid this condition, ms-1007 "needle assembly" procedure in the section 2.23 includes the instruction to inspect the parts after the needle assembly with the hub.Additionally, quality performs the inspection following the qc-0003 section 4.10.*correction and/or corrective action no corrective action is needed due complaint condition cannot confirm, samples returned under the lot 5986 were not available.No further corrective action is necessary.*was the complaint confirmed? no.

Event Description

Report stated "1.Found the tip of the single lumen needle was blunt, and failed for puncture while processing, and the whole procedure was observed by the president of the hospital.So that our customer want to figure out the source of the problem." any patient injury or impact to the gamete or embryo? yes-the patient's surgery was influenced by the problematic needle, and exchange during the procedure.Was a medical or procedural intervention required? no.**(b)(6) 2022- follow-up stated** : what is the extent of patient injury as a result of reported condition? a: patient certainly got injury due to needle exchange.*please explain how the reported condition impacted the surgery.A: physician process in regular way, so if met the situation of aspiration problem; leakage or blunted needle tip, the physician won't continuous the process but exchange to a new needle for complete the procedure.*what procedure was the physician performing? a: oocyte recovery *did the physician perform any extra step to complete the procedure/how did physician complete the procedure? a: just exchange to a new needle for process * was there any significant delay as result of the reported condition? 30 minutes? a: no additionally " 1.Patient with excessive blood loss and extra painful due to needle (ons1733) exchange, because have to pull out the problematic one and change to the new one for instead, which leaded to the second damage.Except that all the procedure just follow the general standards and guidelines.1216677-2022-00255-1 17g wallace oocyte rcvry ons1733 e-complaint-2022-08-0000151.

• Brand Name: 17G WALLACE OOCYTE RCVRY
• Type of Device: 17G WALLACE OOCYTE RCVRY
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 15353821
• MDR Text Key: 305604131
• Report Number: 1216677-2022-00255
• Device Sequence Number: 1
• Product Code: MQE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: D321309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONS1733
• Device Catalogue Number: ONS1733
• Device Lot Number: 5986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other