MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-08-28 for STORZ STRAIGHT COLD KNIFE 27069K manufactured by Karl Storz Endoscopy America, Inc..
[16722174]
During a surgical procedure, the upper one inch of a cold knife blade broke off into the pt's ureteral orifice. The physician was able to retrieve the broken piece without harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008116 |
| MDR Report Key | 1141635 |
| Date Received | 2008-08-28 |
| Date of Report | 2008-08-28 |
| Date of Event | 2008-05-30 |
| Date Added to Maude | 2008-09-09 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ STRAIGHT COLD KNIFE |
| Generic Name | COLD KNIFE |
| Product Code | EZO |
| Date Received | 2008-08-28 |
| Catalog Number | 27069K |
| Lot Number | 34068 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1165021 |
| Manufacturer | KARL STORZ ENDOSCOPY AMERICA, INC. |
| Manufacturer Address | 600 CORPORATE POINTE CULVER CITY CA 902307600 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-08-28 |