MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-04 for CARL STORZ RESECTOSCOPE 28F 27040XB/X manufactured by Carl Storz.
[32993618]
Patient is here for a turbt, and during the procedure the patient started bleeding and physician noticed the resectoscope tip broke inside the patient. Surgeon then had to resect the prostate. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058345 |
| MDR Report Key | 5273130 |
| Date Received | 2015-12-04 |
| Date of Report | 2015-11-23 |
| Date of Event | 2015-11-17 |
| Date Added to Maude | 2015-12-08 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | CARL STORZ RESECTOSCOPE 28F |
| Generic Name | CARL STORZ RESECTOSCOPE 28F |
| Product Code | FDC |
| Date Received | 2015-12-04 |
| Model Number | 27040XB/X |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL STORZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-12-04 |