MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-29 for STRAIGHT COLD KNIFE * 27069K manufactured by Karl Storz Endoscopy America, Inc.
[21658487]
Patient underwent a cystoscopic transurethral incision of the bladder neck. At the close of the case it was noted that the end of the cold knife was missing. The surgeon performed another cystoscopy to locate the tip. The patient had to be placed under general anesthesia. The blade tip was eventually able to be retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2839332 |
| MDR Report Key | 2839332 |
| Date Received | 2012-10-29 |
| Date of Report | 2012-10-29 |
| Date of Event | 2010-08-23 |
| Report Date | 2012-10-29 |
| Date Reported to FDA | 2012-10-29 |
| Date Added to Maude | 2012-11-20 |
| 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 |
| 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 | STRAIGHT COLD KNIFE |
| Generic Name | URETHROTOME, COLD KNIFE |
| Product Code | EZO |
| Date Received | 2012-10-29 |
| Model Number | * |
| Catalog Number | 27069K |
| Lot Number | 38904 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY AMERICA, INC |
| Manufacturer Address | 2151 E. GRAND AVE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-29 |