MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for E8213 manufactured by Gyrus Acmi, Inc..
[136017062]
While instrument was used by surgeon, the bladder biopsy forcep broke inside the patient's bladder. During the procedure, the bladder was irrigated with sorbital. The doctor stated that after examining the bladder there was no harm and no retained pieces of the instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8334711 |
| MDR Report Key | 8334711 |
| Date Received | 2019-02-13 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-12-03 |
| Report Date | 2019-02-05 |
| Date Reported to FDA | 2019-02-05 |
| Date Reported to Mfgr | 2019-02-13 |
| Date Added to Maude | 2019-02-13 |
| 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 |
| 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 |
| Generic Name | FORCEPS, BIOPSY |
| Product Code | GEN |
| Date Received | 2019-02-13 |
| Model Number | E8213 |
| Catalog Number | E8213 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 44857 US 44857 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-13 |