MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-03 for GEISTER MEDIZINTECHNIK/SOLD AS OPTIK, INC. HOOK ELECTRODE 13-3051 (GEISTER) 13-0022 (OPTIK_ manufactured by Geister Medizintechnik.
[1037]
On thursday, october 15, i was notified by sales rep. That a nurse had at a hospital while our rt. Angle electrode. I called the hospital and spoke to the nurse, who said that late the previous day she was testing the electrode by hooking it to their valley generator and activated. She was gloved and had spread k-y jelly in her palm. Upon activation, she felt the current enter her hand and move up her arm. She received a burn on her palm which caused blistering. She was taken to the emergency room and releaseddevice not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122142-1992-00001 |
| MDR Report Key | 1603 |
| Date Received | 1992-11-03 |
| Date of Report | 1992-10-19 |
| Date of Event | 1992-10-14 |
| Date Facility Aware | 1992-10-14 |
| Report Date | 1992-10-19 |
| Date Reported to FDA | 1992-10-19 |
| Date Reported to Mfgr | 1992-10-15 |
| Date Added to Maude | 1992-11-04 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | UNKNOWN |
| 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 | GEISTER MEDIZINTECHNIK/SOLD AS OPTIK, INC. HOOK ELECTRODE |
| Generic Name | HOOK ELECTRODE |
| Product Code | GYA |
| Date Received | 1992-11-03 |
| Model Number | 13-3051 (GEISTER) |
| Catalog Number | 13-0022 (OPTIK_ |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1526 |
| Manufacturer | GEISTER MEDIZINTECHNIK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-11-03 |