MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-10-29 for URETHROTOME K-SE manufactured by Acmi.
[17394823]
Urethrotome used to cut scar tissue. Physician retracted device, could not see blade. Physician found blade stuck in prostate glad. Removed blade. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5013246 |
| MDR Report Key | 1520197 |
| Date Received | 2009-10-29 |
| Date of Report | 2009-10-20 |
| Date of Event | 2009-10-06 |
| Date Added to Maude | 2009-11-06 |
| 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 | 0 |
| 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 | URETHROTOME |
| Generic Name | COLD KNIFE, SERRATED BLAD |
| Product Code | EZO |
| Date Received | 2009-10-29 |
| Model Number | K-SE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACMI |
| Manufacturer Address | SOUTHBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-29 |