MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-04 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Gyrus Acmi, Inc.
[122792546]
The user facility discarded the device after the procedure; therefore, no evaluation will be performed. As part of our investigation, olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result. The cause of the event cannot be determined at this time. 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
[122792547]
Olympus was informed that during a ureteroscopy procedure, while in the renal pelvis the physician was turning the guidewire and the patient? S ureter was perforated. It was reported that prior to the perforation, the physician experienced difficulty with insertion due to the patient? S anatomy. The intended procedure was completed with intervention. The patient? S current condition is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00609 |
| MDR Report Key | 7937061 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-04 |
| Date of Report | 2018-10-04 |
| Date Mfgr Received | 2018-09-21 |
| Date Added to Maude | 2018-10-04 |
| 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 | 0.035" HYBRID WIRE, BOX OF 5 |
| Generic Name | 0.035" HYBRID WIRE |
| Product Code | EYA |
| Date Received | 2018-10-04 |
| Model Number | GWH3505R |
| Catalog Number | GWH3505R |
| Lot Number | UNKNOWN |
| 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 | 1. Required No Informationntervention | 2018-10-04 |