MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-15 for BIPOLAR PROBE UNKNOWN manufactured by Everest Medical.
[19959064]
The doctor indicated that an 89 year old female presented for a gastric hemostasis procedure. After several attempts to cauterize the bleeder, it was noted that the tip of the probe became detached. Two unsuccessful attempts were made in retreiving the probe's tip using forceps. The physician decided to leave the tip in the stomach for natural passage. The patient was discharged without any reported complicationsinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. Invalid data - regarding 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: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. 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 | 1221332-1992-00009 |
| MDR Report Key | 1529 |
| Date Received | 1992-09-15 |
| Date of Report | 1992-09-02 |
| Date Facility Aware | 1992-09-01 |
| Report Date | 1992-09-02 |
| Date Reported to FDA | 1992-09-02 |
| Date Reported to Mfgr | 1992-09-01 |
| Date Added to Maude | 1992-10-23 |
| 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 | BIPOLAR PROBE |
| Generic Name | N/A |
| Product Code | FGM |
| Date Received | 1992-09-15 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | NE920801 |
| ID Number | 61-1992-09-0009 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 1462 |
| Manufacturer | EVEREST MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-09-15 |