PKG., ASSY., STRYKEFLOW 2 WITH TIP 0250070520

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-16 for PKG., ASSY., STRYKEFLOW 2 WITH TIP 0250070520 manufactured by Stryker Endoscopy-san Jose.

Event Text Entries

[186349752] Additional information will be provided once the investigation has been completed. The device manufacturer date is not known at this time. However, should it become available it will be provided in future reports.
Patient Sequence No: 1, Text Type: N, H10


[186349753] It was reported that there was a potential of adverse consequences due to foreign material in sterile packaging.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002936485-2020-00127
MDR Report Key9836535
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-01-03
Date Mfgr Received2020-02-19
Date Added to Maude2020-03-16
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. HANNAH STALNAKER
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 NamePKG., ASSY., STRYKEFLOW 2 WITH TIP
Generic NameAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Product CodeGCX
Date Received2020-03-16
Catalog Number0250070520
Lot Number19252FG2
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ENDOSCOPY-SAN JOSE
Manufacturer Address5900 OPTICAL COURT SAN JOSE CA 95138 US 95138


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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