MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-04 for STRAIGHT COLD KNIFE 27069K manufactured by Storz Karl Storz- Endoskope.
[15632095]
While the surgeon was cutting through scar tissue, the tip of the cold knife broke off into the pt. (urethral meatus had stenosis due to scar tissue. ) the following is from the operative report: a 22 french cystoscope was used for visualization. The cytoscope was introduced with a five french whistle tip catheter which was advanced thru the stricture to guide the scope. While the surgeon was cutting thru "very tough" scar tissue, the cold knife tip broke. The cystoscope and knife were withdrawn. A new knife was opened and reintroduced using a five french whistle tip catheter as a guide. The broken cold knife blade tip was found in the prostatic urethra where the doctor pushed it into the bladder and removed it by using grasping forceps. There was no damage to the urethra from the broken blade.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022544 |
| MDR Report Key | 2022544 |
| Date Received | 2011-02-04 |
| Date of Report | 2011-02-04 |
| Date of Event | 2011-01-05 |
| Report Date | 2011-02-04 |
| Date Reported to FDA | 2011-02-04 |
| Date Added to Maude | 2011-03-17 |
| 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 | COLD KNIFE |
| Product Code | EZO |
| Date Received | 2011-02-04 |
| Model Number | 27069K |
| Catalog Number | 27069K |
| Lot Number | 38506 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STORZ KARL STORZ- ENDOSKOPE |
| Manufacturer Address | 2151 E. GRAND AVE. EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-04 |