MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-31 for EXTENDED SIDE FREEZE CYRO PROBE NONE 2502-P-2400 manufactured by Keeler Instruments, Inc..
[16479566]
Pt in 8/1/96 for a retinal detachment (od) procedure. During the case, one or both of the extended side freeze cyro probes would not freeze, resulting in unnecessary multiple attempts to freeze. Then, causing a rupture of the sclera. Pt required tissue transplant to repair the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 65605 |
| MDR Report Key | 65605 |
| Date Received | 1996-12-31 |
| Date of Report | 1996-08-19 |
| Date of Event | 1996-08-01 |
| Date Facility Aware | 1996-08-01 |
| Report Date | 1996-08-19 |
| Date Reported to Mfgr | 1996-08-19 |
| Date Added to Maude | 1997-01-31 |
| 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 | EXTENDED SIDE FREEZE CYRO PROBE |
| Generic Name | FREEZING PROBES |
| Product Code | HQA |
| Date Received | 1996-12-31 |
| Model Number | NONE |
| Catalog Number | 2502-P-2400 |
| Lot Number | NONE |
| ID Number | SERIES #22-3ESFF-2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 65698 |
| Manufacturer | KEELER INSTRUMENTS, INC. |
| Manufacturer Address | 456 PARKWAY BROOMALL PA 19008 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-12-31 |