MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-02 for CRYOMATIC manufactured by Keeler Instruments, Inc..
[27378963]
Patient Sequence No: 1, Text Type: N, H10
[27378964]
Patient was undergoing right eye pneumatic retinopexy to repair right retinal detachment. Reportedly, the cryoprobe had been checked by staff prior to procedure and found to frost/defrost appropriately. Per medical record, approximately three to four cryotherapy spots were placed around the retinal tear without incident. However, on the fourth activation the probe would not defrost following deactivation of the foot pedal and could not be removed. Reportedly, this resulted in a prolonged freeze. Surgeon then placed countertraction on the globe in order to remove the probe. Patient sustained a conjunctival laceration which was repaired with two sutures. The cryomachine was taken out of service and replaced with a second machine. Procedure completed without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5123513 |
| MDR Report Key | 5123513 |
| Date Received | 2015-10-02 |
| Date of Report | 2015-09-28 |
| Date of Event | 2015-09-15 |
| Report Date | 2015-09-28 |
| Date Reported to FDA | 2015-09-28 |
| Date Reported to Mfgr | 2015-09-28 |
| Date Added to Maude | 2015-10-02 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOMATIC |
| Generic Name | UNIT, CRYOPHTHALMIC, AC-POWERED |
| Product Code | HRN |
| Date Received | 2015-10-02 |
| Returned To Mfg | 2015-01-01 |
| ID Number | 4206 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEELER INSTRUMENTS, INC. |
| Manufacturer Address | 456 PKWY. BROOMALL PA 19008 US 19008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-02 |