MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for RESECTOSCOPE EIS-HCF25 manufactured by Acmi / Olympus Medical System Corporation.
[176577152]
The ceramic tip broke off resectoscope in pt during procedure. The procedure in which it is used, the surgeon has visualization of the resectoscope with a camera. The resectoscope itself has a channel in it to allow the broken pieces to flow out of the pt's bladder without causing damage. After the pieces were removed they were placed together to ensure that all were present. The surgeon did another inspection with the camera to ensure all of the pieces were removed. Lastly, upon completion of the procedure an x-ray of the pelvic was performed to ensure that no pieces were left behind. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092484 |
| MDR Report Key | 9631747 |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-22 |
| Date Added to Maude | 2020-01-27 |
| 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 | 3 |
| Brand Name | RESECTOSCOPE |
| Generic Name | RESECTOSCOPE |
| Product Code | FJL |
| Date Received | 2020-01-24 |
| Model Number | EIS-HCF25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACMI / OLYMPUS MEDICAL SYSTEM CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |