5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE 0233050064

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-06-20 for 5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE 0233050064 manufactured by Stryker Endoscopy-san Jose.

Event Text Entries

[19389366] Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10


[19401187] It was reported that the unit started smoking when activated.
Patient Sequence No: 1, Text Type: D, B5


[30290416] The reported device was not received for investigation; therefore the reported failure cannot be confirmed. The complaint will be closed without a detailed investigation report and based on probable root cause. In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results. The probable root cause for the reported failure involving this device could have been caused by workmanship or use error. The product was not returned for investigation therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10


[30290417] It was reported that the unit started smoking when activated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002936485-2014-00424
MDR Report Key3886998
Report Source07
Date Received2014-06-20
Date of Report2014-05-29
Date of Event2014-05-29
Date Mfgr Received2014-05-29
Date Added to Maude2014-06-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR. THOMAS SHAFER
Manufacturer Street5900 OPTICAL COURT
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal95138
Manufacturer Phone4087542000
Manufacturer G1STRYKER ENDOSCOPY-SAN JOSE
Manufacturer Street5900 OPTICAL COURT
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal Code95138
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE
Generic NameLIGHT, SURGICAL, FLOOR STANDING
Product CodeFSS
Date Received2014-06-20
Catalog Number0233050064
Lot Number085709
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ENDOSCOPY-SAN JOSE
Manufacturer Address5900 OPTICAL COURT SAN JOSE CA 95138 US 95138


Patients

Patient NumberTreatmentOutcomeDate
10 2014-06-20

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