MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-05 for KARL STORZ 27068D * manufactured by Karl Storz Endoscopy - America, Inc..
[17893696]
During urology procedure, storz urethrotome sheath was inserted, with camera. Surgeon and o. R. Nurses noted a band of metal across the scope vision. Urethrotome sheath immediately removed and a piece of metal was removed, by the surgeon, with a hemostat. A sharp edge was noted at the end of the urethrotome. No injury to pt. Urethrotome involved is still in the possession of the facility. Storz notified of incident. Involved product was purchased from storz in 2006 and was used on a few cases. Facility thought they purchased a product that had been used on recent demos. Upon notifying the storz rep after this incident, facility was told, by storz rep, that this product had been in use since 1998.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041861 |
| MDR Report Key | 813040 |
| Date Received | 2007-02-05 |
| Date of Report | 2007-02-05 |
| Date of Event | 2007-01-04 |
| Date Added to Maude | 2007-02-08 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | URETHROTOME SHEATH 21 FR SACHSE |
| Product Code | EZO |
| Date Received | 2007-02-05 |
| Model Number | 27068D |
| Catalog Number | * |
| Lot Number | LD |
| ID Number | L-0200-1.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 800524 |
| Manufacturer | KARL STORZ ENDOSCOPY - AMERICA, INC. |
| Manufacturer Address | 600 CORPORATE POINTE CULVER CITY CA 902307600 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-05 |