MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-13 for USA ELITE CF RESECTOSCOPE INNER SHEATH, 25FR EIS-CFR-25 manufactured by Gyrus Acmi, Inc.
[182775839]
The suspect medical device has not yet been returned to the service center for evaluation/investigation. Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined. However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[182775840]
The service center was informed that during therapeutic transurethral resection of the prostate (turp) procedure, the sheath was inserted into the patient and the tip broke off. The device fragment was successfully retrieve from the patient. The intended procedure was completed with a similar device. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-01222 |
| MDR Report Key | 9466185 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-13 |
| Date of Report | 2020-03-09 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2019-12-13 |
| 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 | USA ELITE CF RESECTOSCOPE INNER SHEATH, 25FR |
| Generic Name | INNER SHEATH |
| Product Code | HIH |
| Date Received | 2019-12-13 |
| Returned To Mfg | 2020-02-13 |
| Model Number | EIS-CFR-25 |
| Lot Number | FW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-12-13 |