MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Gyrus Acmi, Inc.
[122013559]
The device was not returned to olympus for evaluation. The cause of the event cannot be determined at this time. However, this type of guidewire damage is most likely related to the operator's technique. The instruction manual contains several warning and caution statements in an effort to prevent damage to the guidewire. ? Inspect the device for any visible damage such as kinks, unwound coil, abrasion at the tip etc. Carefully and slowly withdraw the guidewire from the patient to avoid any damage. The tips of some metal instruments may cause the coating material on the guidewire to be scraped off under conditions of sharp bending or kinking. If this occurs, it is recommended that any fragments of the outer coating material be removed. While advancing or withdrawing any coated guidewire, avoid sharply bending or kinking the portion of the guidewire that extends beyond the instrument.?
Patient Sequence No: 1, Text Type: N, H10
[122013560]
Olympus was informed that during an ureteroscopy procedure to crush/remove stones, the blue insulation of the guidewire broke off and fell into the patient. The patient? S renal pelvis, ureter and bladder were thoroughly inspected but no fragment was found. It was believed that the device fragment had been flushed away. It was reported that the user felt resistance while attempting to insert the guidewire into the stent due its small diameter. The guidewire damage occurred while the user was withdrawing the stent and then observed the device fragment in the endoscopic view. The guidewire was replaced and the intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00571 |
| MDR Report Key | 7908472 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-08-14 |
| Date Added to Maude | 2018-09-25 |
| 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 | 0 |
| Brand Name | 0.035" HYBRID WIRE, BOX OF 5 |
| Generic Name | 0.035" HYBRID WIRE |
| Product Code | EYA |
| Date Received | 2018-09-25 |
| Model Number | GWH3505R |
| Catalog Number | GWH3505R |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | ERMSIM SCHWOLTBOGEN 24 DETTINGEN, 72581 72581 GM 72581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-25 |