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 currently investigating the reported condition.

Event Description

Additional complaint in reference to e-complaint-(b)(4).Dr.(b)(6) , gynecologist and owner of the vis (b)(6) center in (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.17g wallace oocyte rcvry.Ons1733-750.E-complaint-(b)(4).

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.1216677-2022-00313 17g wallace oocyte rcvry ons1733-750 e-complaint (b)(4).

Manufacturer Narrative

Investigation x-no sample returned x-review dhr analysis and findings.Was the complaint confirmed? no.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 cr_dhr_ons1733-750_619004635.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 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 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.*correction and/or 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.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: 15845667
• MDR Text Key: 307624472
• Report Number: 1216677-2022-00313
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• 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?: Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other