*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-12 for * manufactured by Olympus.

Event Text Entries

[5474882] Olympus and trumpf inc. Was contracted by the operating room (or) materials management department to install a thorascopic video system into our four thoracic or's. Our biomedical engineering department was not notified of this contract and the impending installation. During the installation, a heavy power source was secured to a video monitor cable cover in a very unprofessional and unsafe manner with disregard for safe engineering principals. Images of everything described below will be provided upon request. To begin with, the monitor cable cover was not manufactured to accommodate the attachment of such a heavy power supply. Additionally, the heavy power supplies were attached with cable ties. Cable ties are manufactured to bundle cables, and not support heavy equipment like a power supply. Next, the 120 volt ac power cable was wedged between a sharp edge of the monitors cable cover and support arm. While additional electrical tape appears to have been added to protect the electrical cable from being cut, the monitor cable cover was not constructed for this cable to exit from the cable cover and as such, presents an electrocution hazard if the insulation is cut from anyone putting pressure on the cover, or from the weight of the power supply itself. Next, the power supply was attached with cable ties that were screwed into the cable cover and were not bolted with nuts to ensure the heavy power supply does not fall off. Finally, when the cable cover with the newly installed power supply was replaced on the monitor, it was not properly replaced. Only two of the four attachment points were utilized. Because the technicians decided to run the electrical cable out the side of the cover, it was impossible to utilize all four attachment points that the manufacturer built into the cover because the electrical cable prevented all the holes on the cover from lining up on the monitor attachment points. Furthermore, the two attachment points did not utilize nuts and bolts, but instead only utilized bolts without nuts, making it especially prone to not staying attached. Because of the shoddy work utilized in attaching the power supplies, it resulted in the power supply and the attached cover to fall to the ground, only barely missing hitting the scrub nurse. Unrelated to the power supply issues, but in keeping with the poorly planned and executed installation, all of the video equipment (light source, camera processor, endoflator) was installed on the booms without any rubber feet and causing the equipment to shift at any slight movement of the booms. This situation was corrected after we brought it to their attention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4567896
MDR Report Key4567896
Date Received2015-02-12
Date of Report2013-04-10
Date of Event2013-02-26
Report Date2013-04-10
Date Reported to FDA2015-02-12
Date Reported to Mfgr2015-03-04
Date Added to Maude2015-03-04
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NamePOWER SUPPLY
Product CodeFWC
Date Received2015-02-12
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorPHYSICIAN
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS
Manufacturer Address2400 RINGWOOD AVENUE SAN JOSE CA 95131 US 95131


Patients

Patient NumberTreatmentOutcomeDate
10 2015-02-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.