MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-01-29 for CRYO 4000 AND CRYO PROBE 4010 CR 4000, CR 4010 OPHTHALMIC CRYO manufactured by Mira, Inc..
[19956485]
On two separate occasions dr. Experienced a malfunction of the cr4000 cryo unit and cr4010 cryo probe. After turning the unit on and activating the footswitch, the probe unexpectedly released from the unit. The force was significant. The second incident occurred while a patient was undergoing treatment. While holding the probe, the doctor's hand was forced forward by the pressure of the released probe causing minor damage to the patients conjunctiva. The patient was successfully treated with a backup unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218813-2002-00001 |
| MDR Report Key | 374854 |
| Report Source | 05 |
| Date Received | 2002-01-29 |
| Date of Report | 2002-01-18 |
| Date of Event | 2001-12-19 |
| Date Mfgr Received | 2001-12-19 |
| Date Added to Maude | 2002-02-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR. STEVE TAMSETT |
| Manufacturer Street | 414 QUAKER HIGHWAY |
| Manufacturer City | UXBRIDGE MA 01569 |
| Manufacturer Country | US |
| Manufacturer Postal | 01569 |
| Manufacturer Phone | 5082787877 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYO 4000 AND CRYO PROBE 4010 |
| Generic Name | OPHTHALMIC CRYO PROBE |
| Product Code | HQA |
| Date Received | 2002-01-29 |
| Model Number | CR 4000, CR 4010 |
| Catalog Number | OPHTHALMIC CRYO |
| Lot Number | 13-0901 (CR4010) |
| ID Number | (CR4000) 13-1199 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 363982 |
| Manufacturer | MIRA, INC. |
| Manufacturer Address | 414 QUAKER HIGHWAY UXBRIDGE MA 01569 US |
| Baseline Brand Name | CRYO 4000 AND CRYO PROBE 4010 |
| Baseline Generic Name | OPHTHALMIC CRYO PROBE |
| Baseline Model No | CR 4000, CR 401 |
| Baseline Catalog No | OPHTHALMIC CRYO |
| Baseline ID | (CR4000) 13-119 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-01-29 |