MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-06 for KARL STORZ 26002M * manufactured by Karl Storz Endoscopy-america, Inc..
[71366]
During a pelviscopy procedure, the high frequency cord used with the monopolar endoscopic instrument caught on fire at the joint between the connector to the esu and the cord, severing the cord into two pieces. The fire extinguished itself when the cord was burnt in two. This was the second occurrence of the same event with a different cord.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012235 |
| MDR Report Key | 124662 |
| Date Received | 1997-10-06 |
| Date of Report | 1997-10-03 |
| Date of Event | 1997-09-29 |
| Date Added to Maude | 1997-10-07 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | KARL STORZ |
| Generic Name | HIGH FREQUENCY CORD |
| Product Code | FFZ |
| Date Received | 1997-10-06 |
| Model Number | 26002M |
| Catalog Number | * |
| Lot Number | AP03 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 122044 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 600 CORPORATE POINTE CULVER CITY CA 902307600 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-06 |