MAUDE Adverse Event Report: COOPERSURGICAL, INC. ONS1733-750

Model Number ONS1733-750

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Genital Bleeding (4507)

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currenlty investigating the reported condition.

Event Description

Additional complaint in reference to e-complaint(b)(4).Dr.(b)(6), gynecologist and owner of the vis procreandi ivf center in naples, expressed extreme disappointment about the yield of the ons1733-750 pickup needles (which we sent as a substitution for the backorder of ons1733 that he finds great).Actually he returned 4 out of 10 pieces of the package, since the other 6 have all caused heavy bleeding and he even had to give stitches (that he never gave in over 30 years).According to the doctor, the ons1733-750 do not differ from the ons1733 only in the length of the connection tube but also in the sharp part of the needle.17g wallace oocyte rcvry ons1733-750 e-complaint-(b)(4).

Event Description

Additional complaint in reference to (b)(4).Dr.(b)(6), gynecologist and owner of the (b)(6), expressed extreme disappointment about the yield of the ons1733-750 pickup needles (which we sent as a substitution for the backorder of ons1733 that he finds great).Actually he returned 4 out of 10 pieces of the package, since the other 6 have all caused heavy bleeding and he even had to give stitches (that he never gave in over 30 years).According to the doctor, the ons1733-750 do not differ from the ons1733 only in the length of the connection tube but also in the sharp part of the needle.1216677-2022-00308, 17g wallace oocyte rcvry, ons1733-750, (b)(4).

Manufacturer Narrative

Investigation.X-no sample returned.X-review dhr.*analysis and findings distribution history: the complaint product was manufactured at csi on nov 23rd, 2021, under the work order (b)(4).Manufacturing record review: dhr was reviewed, no events related to lots of suction, aspiration problem or needle blunt were detected during the quality inspections.The dhr can be found in mastercontrol under the infocard title (b)(4).Incoming inspection review: all raw material used to perform the work order (b)(4) was reviewed, lots used to manufacture this lot were complied with the incoming inspection 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, 1 complaint was report to the part number ons1733-750, no complaints was reported related to "lots of suction, aspiration problem or needle blunt.".Product receipt: no samples were available to be evaluated.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product will be returned later, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation : evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product will be returned later, it will be evaluated, and any findings will be appended to this investigation.Root cause : as samples were not available to determinate the root cause, the failure mode "lots of suction, aspiration problem or needle blunt".According to dhr evaluation: 1.The devices were manufactured with the correct items (raw material) per bom.2.No visual or functional fails were found during the quality inspection.3.Flow test or occlusion test performed during the manufacture lot achieve the requirements.Coopersurgical has been implemented in place controls to avoid this kind of situation during the assembly following these procedures.Qc-0003 inspection procedure for single lumen, section 4.9, 4.11 & 4.12, mention: 4.9 hub and needle assembly must measure 330 +/- 2 mm.Of large.Measure with ruler.4.11 assure that the needle orientation is correct according to the drawing.4.12.1 turn on the vision system microvu or the evo cam ii (wall-ecam-xx, refer to ms-1016) take the needle and place the tip on the base of either of the two vision systems so that the tip of the needle could be seen by the screen and adjust the image to be clear.Inspect at 20x magnification using a microvu or similar.Inspect at 15x in the evocam using a lens of 0.62x 4.12.2 inspect the tip of the needle with the next parameters and spin it during the inspection process to assure that the tip has been inspected for all sides.Ms-1017 flow test, mention: "performed 100% of the parts manufactured in the single lumen production line and quality verify this condition following the qc-0029 procedure." ms-1007 needle assembly, procedure in the section 2.23 mention: "inspected 100% of the needle tip.Ensure the inspection tip zoom is in 50%.Remove needles and place the pointed end in the vision block to the right to verify no damage was done to the needle point, using the right side of the monitor.Inspected the needle's tip and slowly turn it during the inspection to make sure it has been inspected on every side according to va-0020.Ms-1020 molding procedure, in the appendix 3 mention: "prior to use the tool check for damages and calibraton status.If the tool is damage or out of calibration, inform to the lead.Note: make sure the one-way valve lid has been loosened counterclockwise before starting the test.2 "instructions for the leak test." ms-1026 ensamble final agujas/needles final assembly section 4.1, mention: "needle´s final assembly inspection at 100% verify that every component is present and correctly assembled.Verify the silicon sleeve is the right color according with the measure and the needle connection is covered with the silicon sleeve.Check the sub-assembly silicon/tube for any visible damages or contamination.Any rejected piece should be placed in the scrap container." corrective action: complaint condition cannot be confirmed due to the samples did not return to coopersurgical to be evaluated.Coopersurgical have been implemented controls to avoid these conditions, furthermore, will continue monitoring this condition for trends.Reason: no further training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: ONS1733-750
• Type of Device: ONS1733-750
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate dr.; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 15833758
• MDR Text Key: 308004762
• Report Number: 1216677-2022-00308
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K012068
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ONS1733-750
• Device Catalogue Number: ONS1733-750
• Device Lot Number: 619004635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other