MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-30 for ACMI EMRS-24 manufactured by Gyrus Acmi.
[4635725]
The 24 fr standard metal resectoscope sheath beak fractured. A portion, the distal portion broke off and was retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037589 |
| MDR Report Key | 3979933 |
| Date Received | 2014-07-30 |
| Date of Report | 2014-07-20 |
| Date of Event | 2014-02-03 |
| Date Added to Maude | 2014-08-06 |
| 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 |
| 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 | ACMI |
| Generic Name | RESECTOSCOPE SHEATH, EMRS-24 |
| Product Code | FDC |
| Date Received | 2014-07-30 |
| Model Number | EMRS-24 |
| Lot Number | CE 0344 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI |
| Manufacturer Address | 136 TURNPIKE RD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-30 |