MAUDE Adverse Event Report: COOPERSURGICAL, INC. KRONNER MANIPUJECTOR

Model Number 6003

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

Ref e-complaint- (b)(4).Report as per request from fda medwatch program.

Event Description

"the dr inserted the kronner during the surgery, and it snap on the way into the patient.The statement was given by the sales rep anglea sears".Reference e-complaint- (b)(4).

• Brand Name: KRONNER MANIPUJECTOR
• Type of Device: KRONNER MANIPUJECTOR
• 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: 6918083
• MDR Text Key: 238843396
• Report Number: 1216677-2016-00083
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904473
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 6003
• Device Catalogue Number: 6003
• Device Lot Number: 206409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other