MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-02 for STORZ manufactured by Karl Storz Endoscopy-america, Inc..
[12874]
Cautery unit discharged current immediately upon hook up of power cable to endo-shears. Appears cause was mfr's cable. Cable has screw-on housing which was loose and when connected to the cautery's unipolar channel, the unit was activated without using the foot pedal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17318 |
| MDR Report Key | 17318 |
| Date Received | 1994-09-02 |
| Date of Report | 1994-09-02 |
| Date of Event | 1994-06-14 |
| Date Facility Aware | 1994-06-14 |
| Report Date | 1994-09-02 |
| Date Reported to FDA | 1994-06-24 |
| Date Reported to Mfgr | 1994-09-02 |
| Date Added to Maude | 1994-11-02 |
| 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 | 0 |
| 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 | STORZ |
| Generic Name | CABLE |
| Product Code | FFY |
| Date Received | 1994-09-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17250 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | CULVER CITY CA 902323578 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1994-09-02 |