MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-05 for SASCH COLD KNIFE 27068K * manufactured by Karl Storz Endoscopy America Inc..
[219574]
Cold knife broke off twice during urologic procedure. No harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023280 |
| MDR Report Key | 359131 |
| Date Received | 2001-11-05 |
| Date of Report | 2001-11-02 |
| Date of Event | 2001-11-01 |
| Date Added to Maude | 2001-11-07 |
| 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 | RISK MANAGER |
| 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 | SASCH COLD KNIFE |
| Generic Name | STRAIGHT COLD KNIFE |
| Product Code | EZO |
| Date Received | 2001-11-05 |
| Returned To Mfg | 2001-11-01 |
| Model Number | 27068K |
| Catalog Number | * |
| Lot Number | 23802 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 348298 |
| Manufacturer | KARL STORZ ENDOSCOPY AMERICA INC. |
| Manufacturer Address | 600 CORPORATE POINTE COLVER CITY CA 902307600 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-11-05 |