MAUDE Adverse Event Report: COOPERSURGICAL, INC. FRIGITONICS; OPTHALMIC CRYO SYSTEM

Model Number CE-2000

Device Problems Device Operates Differently Than Expected (2913); Operating System Becomes Nonfunctional (2996)

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

Event Date 01/26/2015

Event Type  malfunction  

Event Description

The probe froze to the pt's eye and doctor's glove.The whole probe and hose got very cold very suddenly.The machine and probe are being sent in for repair.

Manufacturer Narrative

Ref e-complaint # (b)(4).

• Brand Name: FRIGITONICS
• Type of Device: OPTHALMIC CRYO SYSTEM
• Manufacturer (Section D): COOPERSURGICAL, INC.; trumbull CT
• Manufacturer Contact: nana banafo ; 75 corporate dr.; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 4616022
• MDR Text Key: 5654313
• Report Number: 1216677-2015-00004
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CE-2000
• Device Catalogue Number: CE-2000
• Device Lot Number: 101202
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other