MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-05-21 for RESECTOSCOPE UNKNOWN manufactured by Gyrus Acmi, Inc.
[145693260]
No device was returned to manufacturer for evaluation. The cause of the reported event can not be determined at time. Furthermore, no further information was made available as the manufacturer followed up with the reporter to obtain contact information but with no results.
Patient Sequence No: 1, Text Type: N, H10
[145693261]
On april 23, 2019, the manufacture received medwatch# mw5085877 which states, the doctor was performing an elective transurethral resection of a bladder tumor procedure, when the ceramic tip at the distal end of the resectoscope was noted to be broken off. The broken piece was found in the collection bag at the end of the bed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00856 |
| MDR Report Key | 8629506 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2019-05-21 |
| Date of Report | 2019-10-31 |
| Date of Event | 2019-04-08 |
| Date Mfgr Received | 2019-10-31 |
| Date Added to Maude | 2019-05-21 |
| 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 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| 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 | 2019-05-21 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-21 |