MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-09 for WORKING ELEMENT, MONOPOLAR, 24FR R27050E manufactured by Karl Storz.
[142471574]
Resectoscope loop came loose from working element and lodged in the pt's urethra requiring a forceful removal that resulted in a urethral tear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8528551 |
| MDR Report Key | 8528551 |
| Date Received | 2019-04-09 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-03-21 |
| Date Added to Maude | 2019-04-18 |
| 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 | 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 | WORKING ELEMENT, MONOPOLAR, 24FR |
| Generic Name | MONOPOLAR WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2019-04-09 |
| Returned To Mfg | 2019-03-22 |
| Model Number | R27050E |
| Lot Number | LF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | SOUTHBRIDGE MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-04-09 |