MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.0 ULTEM KOH-EFF,

Model Number AD750-KE30

Device Problem Malposition of Device (2616)

Patient Problem Uterine Perforation (2121)

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reference e-complaint- (b)(4).When the delineator was being pushed in to delineate the cervix, the cup slid all the way back and the tip perforated the uterus.

• Brand Name: STERILE 3.0 ULTEM KOH-EFF,
• Type of Device: STERILE 3.0 ULTEM KOH-EFF,
• 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: 6906942
• MDR Text Key: 240340479
• Report Number: 1216677-2017-00046
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143650
• 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: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2017
• Device Model Number: AD750-KE30
• Device Catalogue Number: AD750-KE30
• Device Lot Number: 162-16
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• 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