MAUDE Adverse Event Report: COOPERSURGICAL, INC. POTOCKY NEEDLE

Model Number 6066

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

As per request from fda medwatch program.

Event Description

"very limited information no dates, no serial numbers amount of needles used was several? or how many times the needles were inserted when needle was inserted into the patient the ball sleeve remained had to remove with forceps lidocaine was used for removal.Everything was thrown out nothing to return." ref e-complaint (b)(4).

• Brand Name: POTOCKY NEEDLE
• Type of Device: POTOCKY NEEDLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6392927
• MDR Text Key: 245313070
• Report Number: 1216677-2016-00084
• Device Sequence Number: 1
• Product Code: HEE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6066
• Device Catalogue Number: 6066
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other