MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-25 for KARL STORZ 27069K manufactured by Karl Storz Gmbh & Co. Kg.
[20841703]
The dr was performing a direct visual internal urethrotomy and tur on a male, when midway through the procedure 2 cm of the cold knife blade plus shaft broke off in pt. Dr searched but could not find the broken piece due to the site being too bloody to attain good visual; he used extensive irrigation to try and clear the field, but could not find the piece. At that time, dr stopped procedure. Pt was rescheduled and dr was successful in retrieving the broken piece and completing the original procedure with no pt impact. Pt condition post-op was good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-2007-00014 |
| MDR Report Key | 974952 |
| Date Received | 2007-05-25 |
| Date of Report | 2007-05-25 |
| Date of Event | 2007-04-25 |
| Date Facility Aware | 2007-04-25 |
| Report Date | 2007-05-25 |
| Date Reported to FDA | 2007-05-25 |
| Date Reported to Mfgr | 2007-05-25 |
| Date Added to Maude | 2008-01-08 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | KARL STORZ |
| Generic Name | COLD KNIFE |
| Product Code | EZO |
| Date Received | 2007-05-25 |
| Model Number | 27069K |
| Catalog Number | 27069K |
| Lot Number | 32004 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 DAY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 943154 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | * TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-25 |