MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-04 for STRAIGHT COLD KNIFE * 27069K manufactured by Karl Storz.
[1411098]
The tip of the cold knife broke off during the procedure. The first time the tip was retrieved with some difficulty. This was done using a grasping forceps from the urethra via cystoscope. However, since the intended procedure was not yet complete, a second cold knife was used. The second time the tip broke off and could not be retrieved via cystoscopy. The c-arm was then used to visualize and the tip was seen in the retroperitoneal space. The surgeon had to do an exploratory laparotomy and a perineal exploration to retrieve the tip. It was found close to a major vessel but had not penetrated any vital structures. A third device was opened but not used on the patient for comparison with the fluoro images and this device broke in the same place as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1731769 |
| MDR Report Key | 1731769 |
| Date Received | 2010-06-04 |
| Date of Report | 2010-06-02 |
| Date of Event | 2010-06-02 |
| Report Date | 2010-06-02 |
| Date Reported to FDA | 2010-06-04 |
| Date Added to Maude | 2010-06-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | STRAIGHT COLD KNIFE |
| Generic Name | URETHROTOME, COLD KNIFE, DISPOSABLE |
| Product Code | EZO |
| Date Received | 2010-06-04 |
| Model Number | * |
| Catalog Number | 27069K |
| Lot Number | 38237 ALL 3 SAME LOT # |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2010-06-04 |