MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for RESECTOSCOPE SHEATH EIS HCF25 manufactured by Olympus Medical Products Czech.
[141105323]
During procedure for cystoscopy, surgeon noted plastic tip of resectoscope broke off. Surgeon was able to retrieve broken tip. No procedure complications noted and no harm to the pt. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085596 |
| MDR Report Key | 8487031 |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-02 |
| Date of Event | 2018-07-31 |
| Date Added to Maude | 2019-04-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 SHEATH |
| Generic Name | RESECTOSCOPE |
| Product Code | FDC |
| Date Received | 2019-04-04 |
| Model Number | EIS HCF25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL PRODUCTS CZECH |
| Manufacturer Address | US |
| Brand Name | RESECTOSCOPE SHEATH |
| Generic Name | RESECTOSCOPE |
| Product Code | FDC |
| Date Received | 2019-04-04 |
| Model Number | EIS HCF25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL PRODUCTS SZECH |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-04 |