MAUDE Adverse Event Report: KEELER LTD. KEELER CRYOMASTER; CRYOSURGICAL CONSOLE

Model Number CRYOMASTER

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2013

Event Type  malfunction  

Event Description

During a cryosurgical procedure the device entered into a purging state unexpectedly.During the time the tip remained frozen and in contact with the patient's eye, and it was not possible to break contact with the eye until the tip had defrosted for fear of causing harm to the pt.It was necessary for the procedure to be halted.The pt was seen in clinic shortly after the event, and it was determined that no damage had occurred as a result.This event occurred in the (b)(6), and has been registered with the (b)(6).

• Brand Name: KEELER CRYOMASTER
• Type of Device: CRYOSURGICAL CONSOLE
• Manufacturer (Section D): KEELER LTD.; clewer hill rd.; windsor, berkshire SL4 4 AA; UK SL4 4AA
• Manufacturer Contact: clewer hill rd.; windsor, berkshire SL4 4-AA ; 753827155
• MDR Report Key: 3727381
• MDR Text Key: 18793244
• Report Number: 1000391004-2014-00001
• Device Sequence Number: 1
• Product Code: HKY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CRYOMASTER
• Device Catalogue Number: 2502K8035/2502K8040
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/15/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2000
• 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): Required Intervention