MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-17 for MIRA * CR 4010 manufactured by Mira.
[176880]
Pt was being treated for a retinal detachment with a scleral buckir procedure in pt's right eye. During the use of the cryo probe the cryo probe malfunctioned and discharged a large burst, jet of gas at the globe. The gas pressure had also remained in the green range (about 700 psi) throughout the case. This resulted in transmission of force to the eye resulting in inadvertent retinal hole. Subretinal hemorrhage and vitreous hemorrhage. Pt developed a recurrent retinal detachment for which pt underwent a vitrectomy. That probe was removed from circulation.
Patient Sequence No: 1, Text Type: D, B5
[6081388]
Pt was being treated for a retinal detachment with a scleral buckir procedure in their right eye. During the use of the cryo probe the cryo probe malfunctioned and discharged a large burst, jet of gas at the globe. The gas pressure had also remained in the green range (about 700 psi) throughout the case. This resulted in transmission of force to the eye resulting in inadvertent retinal hole. Subretinal hemorrhage and vitreous hemorrhage. They developed a recurrent retinal detachment for which they underwent a vitrectomy. That probe was removed from circulation.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | 259595 |
| MDR Report Key | 259595 |
| Date Received | 2000-01-17 |
| Date of Report | 2000-01-17 |
| Date of Event | 1999-11-18 |
| Date Facility Aware | 1999-11-18 |
| Date Reported to FDA | 2000-01-17 |
| Date Reported to Mfgr | 2000-01-17 |
| Date Added to Maude | 2000-01-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIRA |
| Generic Name | CRYOPROBE |
| Product Code | HPS |
| Date Received | 2000-01-17 |
| Model Number | * |
| Catalog Number | CR 4010 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 251399 |
| Manufacturer | MIRA |
| Manufacturer Address | 87 RUMFORD WALTHAM MA 02154 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-01-17 |
| 2 | 0 | 1. Required No Informationntervention | 2000-01-17 |