MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for SACHSE STRAIGHT COLD KNIFE manufactured by Karl Storz Endoscopy America, Inc..
[119219444]
During a cystourethroscopy, the surgeon using utilizing a cold knife attachment and went to deploy the trigger on the device to make the appropriate cut, the trigger did not engage and a continued attempt proved to continue the disengagement of the device trigger. The surgeon removed the scope and visualized that the cold knife's metal tube was outside the rubber sheath of the device. The surgeon detached the cold knife and utilized a new one. Small fragments of metal were retained in pt which were easily irrigated out. No harm to pt was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079530 |
| MDR Report Key | 7842233 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-27 |
| Date Added to Maude | 2018-09-04 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SACHSE STRAIGHT COLD KNIFE |
| Generic Name | COLD KNIFE |
| Product Code | EZO |
| Date Received | 2018-08-31 |
| Lot Number | 37KG2224 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY AMERICA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-31 |