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

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

*what are the details of the complaint? is there anything else? dr.(b)(6), gynecologist and owner of (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.Additional complaints: (b)(4).

Manufacturer Narrative

Correction to sections d1 and d2 coopersurgical, inc.Is currenlty investigating the reported condition.

Event Description

*what are the details of the complaint? is there anything else? 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.Additional complaints: 2022-11-0000364, 2022-11-0000365, 2022-11-0000366, 2022-11-0000367, 2022-11-0000368.

• 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 dr.; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 15833292
• MDR Text Key: 307917454
• Report Number: 1216677-2022-00307
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• 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