MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for INNER SHEATH, FOR 26 FR. OUTER SHEATH A22040A manufactured by Olympus Winter & Ibe Gmbh.
[184038505]
The service center received a medwatch report, mw5092847, on february 26, 2020 for one bipolar resectoscope sheath which tip broke during a procedure. The report was for model a22040a, rigid cystoscope sheath, lot number 131w-0213, that was used by a physician during a rigid cystoscopy. It was reported the urologist observed a gray/silver- colored, half-circle shaped item present in the bladder during the procedure. Upon inspection of the device, urology noted the tip of the bipolar cystoscope sheath was broken and missing. The physician obtained an x-ray, and the patient was transferred to a tertiary site for removal of the broken piece and management of the condition. The medwatch report indicated that this was a serious injury and no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2020-00382 |
| MDR Report Key | 9849865 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-03-13 |
| Date Facility Aware | 2020-02-26 |
| Report Date | 2020-02-26 |
| Date Reported to Mfgr | 2020-02-26 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | INNER SHEATH, FOR 26 FR. OUTER SHEATH |
| Generic Name | RESECTOSCOPE SHEATH |
| Product Code | HIH |
| Date Received | 2020-03-18 |
| Model Number | A22040A |
| Catalog Number | A22040A |
| Lot Number | 131W-0213 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |