MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-12 for STRAIGHT COLD KNIFE 27069K manufactured by Storz (karl Storz) Endoscope.
[3112358]
During cystoscopy with tur bladder neck contracture surgeon was using a straight cold knife part# 27069k, lot# 41241 and the blade broke off. Broken piece retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026935 |
| MDR Report Key | 2748018 |
| Date Received | 2012-09-12 |
| Date of Report | 2012-08-31 |
| Date of Event | 2012-08-31 |
| Date Added to Maude | 2012-09-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRAIGHT COLD KNIFE |
| Generic Name | NONE |
| Product Code | EZO |
| Date Received | 2012-09-12 |
| Catalog Number | 27069K |
| Lot Number | 41241 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STORZ (KARL STORZ) ENDOSCOPE |
| Manufacturer Address | EL SEGUNDO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-12 |