MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP REDIKIT,W/EPINEPHRIN

Model Number 6061

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

Report as per request from fda medwatch program.

Event Description

Per (b)(6), while the physician was performing a cervical block, the potocky needle provided with the leep redikit broke in two.One of the halves was in the pt but it was able to be retrieved.Per diane, this is an isolated incident.Ref e-complaint- (b)(4).

• Brand Name: LEEP REDIKIT,W/EPINEPHRIN
• Type of Device: LEEP REDIKIT,W/EPINEPHRIN
• 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: 6918855
• MDR Text Key: 239717069
• Report Number: 1216677-2016-00082
• Device Sequence Number: 1
• Product Code: HEE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910253
• 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: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2017
• Device Model Number: 6061
• Device Catalogue Number: 6061
• Device Lot Number: 211595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other