MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-05 for E-LINE 8655334 8655.334 manufactured by Richard Wolf Medical Instruments Corp..
[71718998]
Patient Sequence No: 1, Text Type: N, H10
[71718999]
The surgeon was using the device during a hysteroscopy procedure and it broke inside of the body cavity during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6460166 |
| MDR Report Key | 6460166 |
| Date Received | 2017-04-05 |
| Date of Report | 2017-03-22 |
| Date of Event | 2017-03-20 |
| Report Date | 2017-03-22 |
| Date Reported to FDA | 2017-03-22 |
| Date Reported to Mfgr | 2017-03-22 |
| Date Added to Maude | 2017-04-05 |
| 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 | 3 |
| Brand Name | E-LINE |
| Generic Name | RESECTOSCOPE, WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2017-04-05 |
| Model Number | 8655334 |
| Catalog Number | 8655.334 |
| ID Number | 22.5/24.5 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Address | 353 CORPORATE WOODS PKWY. VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-05 |