UNKNOWN_ENDOSCOPY_PRODUCT UNK_END

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-28 for UNKNOWN_ENDOSCOPY_PRODUCT UNK_END manufactured by Stryker Endoscopy-san Jose.

Event Text Entries

[23040456] Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10


[23040457] It was reported that the light cord was activating on its own while it was placed in standby mode.
Patient Sequence No: 1, Text Type: D, B5


[27007064] 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 and the investigation will be updated with the new results. Probable root cause for the reported failure involving this device could not be determined due to insufficient information. 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


[27007205] It was reported that the light cord was activating on its own while it was placed in standby mode.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002936485-2015-00681
MDR Report Key4946996
Date Received2015-07-28
Date of Report2015-07-02
Date of Event2015-07-02
Date Mfgr Received2015-07-02
Date Added to Maude2015-07-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KIMBERLY LYNCH
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 NameUNKNOWN_ENDOSCOPY_PRODUCT
Generic NameLIGHT, SURGICAL, FLOOR STANDING
Product CodeFSS
Date Received2015-07-28
Catalog NumberUNK_END
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 2015-07-28

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