MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-15 for STORZ - COLD KNIFE ENDOSCOPE 27069K manufactured by Storz.
[1954133]
Part of the knife tip broke off in pt's bladder during surgery. The md was able to retrieve the piece with grasper. No harm was done to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019842 |
| MDR Report Key | 2025227 |
| Date Received | 2011-03-15 |
| Date of Report | 2011-03-15 |
| Date of Event | 2011-02-18 |
| Date Added to Maude | 2011-03-28 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | STORZ - COLD KNIFE ENDOSCOPE |
| Generic Name | COLD KNIFE |
| Product Code | EZO |
| Date Received | 2011-03-15 |
| Returned To Mfg | 2011-03-15 |
| Model Number | 27069K |
| Catalog Number | 27069K |
| Lot Number | 40885 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STORZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-15 |