MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-27 for OPHTHALMIC DIATHERMY TR3000 manufactured by Mira, Inc..
[13991]
Pt with stab wound to left eye, ruptured globe and lid laceration. One day after the surgical repair (of scleral corneal, and lid laceration) pt had hemorrhage. A second surgery done 10 days later for vitrectomy/lensectomy/drainage of hemmorrhage. During this second surgery, the diathermy machine would not turn off power to the diathermy tip when the surgeon took his foot off the control pedal. As a result, the tip would stick to the pt's sclera. Because the eye has sustained such extensive damage from the original stab injury, there was no hope for survival of the globe or useful vision, and the surgery was stopped. Biomed checked the diathermy unit and found defective footpedal socket. The socket was replaced and the diathermy machine was tested and determined to be working correctly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005243 |
| MDR Report Key | 19996 |
| Date Received | 1995-02-27 |
| Date of Report | 1995-02-01 |
| Date of Event | 1995-01-11 |
| Date Added to Maude | 1995-02-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPHTHALMIC DIATHERMY |
| Generic Name | OPHTHALMIC DIATHERMY |
| Product Code | HQR |
| Date Received | 1995-02-27 |
| Model Number | TR3000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19891 |
| Manufacturer | MIRA, INC. |
| Manufacturer Address | WALTHAM MA 021543846 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-02-27 |