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

Model Number AD750-KE30

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).

Event Description

The customer reported over the phone that the product came apart during surgery.The procedure was extended because the performing physician had to get a new unit to finish the procedure.No adverse events were reported.

• 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: peter niziolek ; 75 corporate drive; trumbull, CT 06611
• MDR Report Key: 8424424
• MDR Text Key: 139054453
• Report Number: 1216677-2019-00128
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/14/2021
• Device Model Number: AD750-KE30
• Device Catalogue Number: AD750-KE30
• Device Lot Number: 073-18
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1