MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH CUPS 3.5CM.ULTEM (2)

Model Number KCP-35-2

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/22/2019

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 cup was badly damaged after a single use seemed to be not as strong as the other cup in the package.States that they used the alternate cup and after first use it was in better shape than the first dr states he used the same settings while using both cups and one seemed to be extremely damaged after first use and the other held shape.

• Brand Name: KOH CUPS 3.5CM.ULTEM (2)
• Type of Device: KOH CUPS 3.5CM.ULTEM (2)
• 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: 8394745
• MDR Text Key: 138232335
• Report Number: 1216677-2019-00116
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954311
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: KCP-35-2
• Device Catalogue Number: KCP-35-2
• Device Lot Number: 228692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1