MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-07 for OLYMPUS manufactured by Olympus.
[178543371]
Upon rigid cystoscopy with bipolar cystoscope instrumentation, urologist noted a gray / silver-colored, half-circle shaped item present in the bladder. Upon inspection of instrumentation, urology noted the tip of the bipolar cystoscope sheath was broken and missing. X-ray obtained. Pt transferred to tertiary site for management of underlying condition. Object from resectoscope removed during procedure at the subsequent facility. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092847 |
| MDR Report Key | 9686512 |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-03-13 |
| Date Added to Maude | 2020-02-10 |
| 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 | OLYMPUS |
| Generic Name | RESECTOSCOPE |
| Product Code | FJL |
| Date Received | 2020-02-07 |
| Lot Number | 131W-0213 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | A22040A DE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-02-07 |