MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.5 ULTEM KOH-EFF

Model Number AD750-KE35

Device Problem Sparking (2595)

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

Event Date 05/31/2018

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

Sparking on the koh cup.

• Brand Name: STERILE 3.5 ULTEM KOH-EFF
• Type of Device: STERILE 3.5 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: 8391543
• MDR Text Key: 138214592
• Report Number: 1216677-2019-00112
• 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: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2020
• Device Model Number: AD750-KE35
• Device Catalogue Number: AD750-KE35
• Device Lot Number: 256-17
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1