MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-02-23 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Osta.
[68211899]
The device was not returned to olympus for evaluation. The cause of the reported event could not be determined. Based on similar reports, 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. "do not apply excessive force to advance or withdraw the guidewire. If resistance is encountered, determine the cause and take remedial action before continuing. When using a moveable core guidewire, do not attempt to advance, stiffen or straighten the tip of the guidewire against resistance. Do not reshape or alter the configuration of the guidewire. Doing so may compromise the structural integrity of the guidewire and may result in complications. "
Patient Sequence No: 1, Text Type: N, H10
[68211900]
Olympus was informed that during an ureteroscopy procedure, the outer stainless steel wire unraveled on the guidewire inside the patient. The device fragments were removed using an alligator forcep. There was minimal bleeding observed that resolved on its own. It was reported that the procedure was prolonged 30 minutes. The intended procedure was completed. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[74395162]
The device was sent to the original equipment manufacturer (oem) for evaluation. The evaluation was not able to confirm the exact lot number for this device. Production documents of the possible involved lot numbers provided by the user were reviewed and revealed no deviation or irregularity. The production of these lots has been done according to the valid specifications. On the complaint product we could not determine any manufacturing defects. A visual inspection found that there is a non-ductile fracture and the breaking edge has a tempering color. The surface next to the fracture also has damages. Therefore, it can be concluded that during the application, the guide wire was left as a safety wire in the application and was damaged by a laser. The ifu describes that the guide wire has to be withdrawn to a position in which it cannot be damaged when using energy-emitting products (e. G. Laser). The oem investigation confirmed the damage on the guide wire but has determined it to not be related to the manufacture of the product. This guide wire was likely damaged by a laser during use by the surgeon. This was confirmed as a possibility by the olympus rep.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2017-00112 |
| MDR Report Key | 6355382 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-02-23 |
| Date of Report | 2017-04-28 |
| Date Mfgr Received | 2017-04-12 |
| Date Added to Maude | 2017-02-23 |
| 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 | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 0.035" HYBRID WIRE, BOX OF 5 |
| Generic Name | 0.035" HYBRID WIRE |
| Product Code | EYA |
| Date Received | 2017-02-23 |
| Returned To Mfg | 2017-03-16 |
| Model Number | GWH3505R |
| Catalog Number | GWH3505R |
| Lot Number | UNKNOWN |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTA |
| Manufacturer Address | ERMSIM SCHWOLTBOGEN 24 DETTINGEN, 72581 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-23 |