MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-29 for KEELER CRYOMASTER 2502K8035/2502K8040 manufactured by Keeler Ltd..
[18793244]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000391004-2014-00001 |
| MDR Report Key | 3727381 |
| Report Source | 06 |
| Date Received | 2014-01-29 |
| Date of Report | 2014-01-28 |
| Date of Event | 2013-12-03 |
| Date Mfgr Received | 2013-12-10 |
| Device Manufacturer Date | 2000-04-01 |
| Date Added to Maude | 2014-05-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | CLEWER HILL RD. |
| Manufacturer City | WINDSOR, BERKSHIRE SL4 4AA |
| Manufacturer Country | UK |
| Manufacturer Postal | SL4 4AA |
| Manufacturer Phone | 753827155 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KEELER CRYOMASTER |
| Generic Name | CRYOSURGICAL CONSOLE |
| Product Code | HKY |
| Date Received | 2014-01-29 |
| Returned To Mfg | 2013-12-15 |
| Model Number | CRYOMASTER |
| Catalog Number | 2502K8035/2502K8040 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEELER LTD. |
| Manufacturer Address | CLEWER HILL RD. WINDSOR, BERKSHIRE SL44AA UK SL4 4AA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-29 |