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

Model Number ONS1733LL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation process is completed a follow-up report will be filed.Reference (b)(4).

Event Description

Needle failed during the procedure.Patient had excessive bleeding and needed to be sent to the er for treatment after the retrieval procedure.Ref (b)(4).

Manufacturer Narrative

Reference e-complaint-(b)(4).Investigation x-initiated manufacturer's investigation x-no sample returned x-review dhr x-inspect stock product *analysis and findings distribution history.The complaint (b)(4) was manufactured at csi on june 29th, 2018 under work order (b)(4).Manufacturing record review the dhr- for this unit was reviewed and no non-conformities, related to the complaint condition, was noted.Incoming inspection review iqc-records for the needle was reviewed and no non-conformities, related to the complaint condition, was noted.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.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.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 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.By the other hand, according to the hospital report the excessive bleeding was not generated due to the needle quality.There is a 100% needle tip inspection currently to detect incorrect needle quality inside de single lumen manufacturing process.One sample was reviewed from fg inventory of the same lot 1206, the evaluation revealed no correlation between the product and the excessive bleeding to the patient.Root cause the most probable root cause is due to incorrect usage of the product.The devices complied with the quality requirements and there is not similar reported complaint with this kind of problem *correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further corrective action is necessary, as the complaint condition was not confirmed.*was the complaint confirmed? no.

Event Description

Needle failed during the procedure.Patient had excessive bleeding and needed to be sent to the er for treatment after the retrieval procedure.Ref e-complaint-(b)(4).

Event Description

Needle failed during the procedure.Patient had excessive bleeding and needed to be sent to the er for treatment after the retrieval procedure.Ref: (b)(4).

Manufacturer Narrative

Reference: (b)(4).Additional information request: subject: report number.1.Please confirm or provide the model, lot, serial, and / or catalog number(s) of the device listed in the above listed medical device reports as applicable.Model catalog number: ons1733ll, lot/serial number: (b)(6).2.Please provide the total number of devices manufactured, distributed and, if available, used per year over the last three years for the medical device identified in the medical device report.Please indicate the proportions distributed in the us and outside the us.Lot# #devices manufactured units distributed us ous 1206 2600 (b)(4) (b)(4) 0 over the last 3 years from june 1, 2018 to may 31, 2020, (b)(4) units of the ons1733ll have been distributed globally.3.Please provide a copy (or electronic location) of all current labeling for the device, including directions for use, caution statements, technical manuals, and product performance reports.This information can be found at the following locations; https://fertility.Coopersurgical.Com/wp-content/uploads/single_lumen_ifu.Pdf.Wallace single lumen oocyte recovery systems: coopersurgical fertility companies.4.Please identify the exact location in the labeling where users are warned of steps to take to prevent the "incorrect usage" of the device and subsequently causing excessive bleeding to the patient from occurring, and/or how to mitigate the problem should it occur.The following warning with the instructions for use (ifu) provides guidance on the correct application of the device to prevent tissue damage.Subsequently, section 12 provides the following guidance to mitigate the problem should it occur.5.Please provide any evaluation of the event described in the medical device reports by the attending physician, surgeon, hospital representative or health care professional.Based on subsequent communications with the account, the excessive bleeding was not associated with the needle quality.6.Please provide any evaluation of other information used by your firm to determine whether the events described in the medical device reports are or are not attributable to the devices.A review of a 2-year complaint history did not show similar reported complaint conditions, other than these reported by the same facility.The evaluation found that the device history record (dhr) for this lot displayed no abnormalities.A visual inspection was performed and displayed no abnormalities.A functional evaluation of the product returned against this complaint found it to meet quality release specifications for needle penetration force testing.Although a secondary condition unrelated to the reported condition was noted, where the product presented a reduction of the aspiration tubes inner diameter, having no influence on patient safety, being addressed through product enhancements.The investigation concluded that excessive bleeding was not associated with the quality of the device, as confirmed by the account.7.Provide testing completed during device design that validates these oocyte recovery needles meets the needs of the user.The 5 year shelf life study for the product documented under: (b)(4), revision a, effective january 31, 2019 was developed based on customer requirements, which includes needle penetration force testing to determine needle sharpness under section 4.9.10.This testing yielded an average of 1.03 newtons verified to be well below the 2.0 newton maximum penetration force specification with the sampling yielding a 1.33 cpk process capability, which is verified at manufacture during the quality control release inspection.

• Brand Name: 17G WALLACE OOCYTE RCVRY
• Type of Device: 17G WALLACE OOCYTE RCVRY
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull, ct CT 06611
• MDR Report Key: 9138703
• MDR Text Key: 183254307
• Report Number: 1216677-2019-00271
• Device Sequence Number: 1
• Product Code: MQE
• Combination Product (y/n): N
• PMA/PMN Number: K012068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/25/2023
• Device Model Number: ONS1733LL
• Device Catalogue Number: ONS1733LL
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other