FDA.reportPublic FDA data

MAUDE MDR 8137996

MDR report key
8137996
Report number
2021898-2018-00550
Event key
0
Event type
3
Date of event
2018-11-08
Date received
2018-12-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STACY RUEMPING
Address
7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHANNEL NEUROENDOSCOPE, 30K, 2MM, SHORT, HIGH RESOLUTIONENDOSCOPE, NEUROLOGICALMEDTRONIC NEUROSURGERYGWG2233-0052233-005E39190Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-060

Event Narratives#

N

Patient 1

THE CHANNEL NEUROENDOSCOPE WAS RETURNED WITH A BURNT-OUT ILLUMINATION CONNECTOR END. THEREFORE, THE FUNCTIONALITY TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE ILLUMINATION CONNECTOR END. IT IS NOT KNOWN HOW OR WHEN THIS DAMAGE OCCURRED. HOWEVER, IT COULD HAVE BEEN THE RESULT OF THE ILLUMINATION CONNECTOR BEING CONNECTED TO AN INCOMPATIBLE LIGHT CABLE. THE IFU CAUTIONS THAT, ?THE ENDOSCOPE SHOULD ONLY BE CONNECTED TO A COMPATIBLE LIGHT CABLE. OTHER LIGHT CABLES COULD OVERHEAT AND DAMAGE THE ILLUMINATION CONNECTOR ON THE ENDOSCOPE.? IT FURTHER CAUTIONS THAT, ?DO NOT CONNECT THE ENDOSCOPE DIRECTLY TO THE LIGHT SOURCE OR THE ILLUMINATION CONNECTOR MAY OVERHEAT.? IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

IT WAS REPORTED THAT THE ENDOSCOPE FAILED UPON USE. ONE END OF THE ENDOSCOPE WAS BURNT.