0.035" HYBRID WIRE, BOX OF 5 GWH3505R

MAUDE Adverse Event Report

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 2017-12-01 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Gyrus Acmi, Inc.

Event Text Entries

[94808096] 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


[94808097] Olympus was informed that at the conclusion of a percutaneous nephrolithotomy procedure, as the surgeon began to withdraw the guidewire the distal end began to unravel in the patient. The user facility reported no device fragment from the guidewire or the guidewire's insulation fell inside the patient. The surgeon was able to retrieve the guidewire without intervention. The intended procedure was completed with the same guidewire. The procedure was delayed 5-10 minutes. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951238-2017-00750
MDR Report Key7075209
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2017-12-01
Date of Report2017-12-01
Date of Event2017-11-09
Date Mfgr Received2017-11-10
Date Added to Maude2017-12-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone408935-512
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name0.035" HYBRID WIRE, BOX OF 5
Generic Name0.035" HYBRID WIRE
Product CodeEYA
Date Received2017-12-01
Model NumberGWH3505R
Catalog NumberGWH3505R
Lot Number91606131
ID NumberUDI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGYRUS ACMI, INC
Manufacturer AddressERMSIM SCHWOLTBOGEN 24 DETTINGEN, 72581 72581 GM 72581


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-01

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