MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-17 for ROTATING CF RESECTOSCOPE VISUAL OBTURATOR, 25FR ERVO-CF25 manufactured by Gyrus Acmi Inc.
[22457372]
The device referenced in this report has been returned to olympus for evaluation. The reported phenomenon which stated that the white tip of the device came off after placing in the bladder was not confirmed. A visual and mechanical testing was performed. The release button was found to be loose from the lock ring and pin assembly. The o-ring was also missing from the lock body causing the device to fail the leak test. This could be attributed to normal wear of the device. The instruction for use states, "examine the device prior to use. Do not use if damage is found. "
Patient Sequence No: 1, Text Type: N, H10
[22457373]
Olympus was informed that during an unspecified procedure, the white tip of the device came off after placing in the bladder. No further information was provided. Olympus made multiple attempts to obtain additional information via telephone and in writing, but with no success.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2015-00305 |
| MDR Report Key | 4922966 |
| Date Received | 2015-07-17 |
| Date of Report | 2015-07-02 |
| Date of Event | 2015-07-02 |
| Date Mfgr Received | 2015-07-02 |
| Date Added to Maude | 2015-07-17 |
| 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 NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROTATING CF RESECTOSCOPE VISUAL OBTURATOR, 25FR |
| Generic Name | ROTATING CF RESECTOSCOPE VISUAL OBTURATOR, 25FR |
| Product Code | FDC |
| Date Received | 2015-07-17 |
| Returned To Mfg | 2015-07-02 |
| Model Number | ERVO-CF25 |
| Catalog Number | ERVO-CF25 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 017722104 US 017722104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-17 |