MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-10 for * 26006M manufactured by Karl Storz Endoscopy-america, Inc..
[317806]
An esu cautery cord caught fire during a procedure. The fire was described as sparks and smoke only, no actual fire. The cord and esu were removed from the room. No injury was caused to the patient. The reporting nurse said that the users [surgical techs] had bent the cord and taped it to the scissors to keep the connector from falling out. Device usage problem: device failed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 489102 |
| MDR Report Key | 489102 |
| Date Received | 2003-10-10 |
| Date of Report | 2003-01-01 |
| Date of Event | 2002-12-01 |
| Date Added to Maude | 2003-10-17 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | ELECTROSURGICAL UNIT ACTIVE ELECTRODE UNIPOLAR CORD |
| Product Code | FFZ |
| Date Received | 2003-10-10 |
| Model Number | * |
| Catalog Number | 26006M |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 477888 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 600 CORPORATE POINTE CULVER CITY CA 902307600 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2 | 1. Other | 2003-10-10 |