GASTROSCOPE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for GASTROSCOPE manufactured by Stryker Endoscopy.

Event Text Entries

[173502275] Gastroscope was being used in a procedure and a picture couldn't be used due to it "flipping". A stryker rep was called to assist. An attempt was made to replace the data cord, but there was no change. The tower was replaced, but there was no change. Brought in a monitor tower to sync picture, but there was no change. A different scope was exchanged and that solved the problem. The defective scope was removed from service by the stryker rep.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9544227
MDR Report Key9544227
Date Received2020-01-03
Date of Report2019-10-03
Date of Event2019-10-03
Report Date2019-10-03
Date Reported to FDA2019-10-03
Date Reported to Mfgr2020-01-03
Date Added to Maude2020-01-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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 FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGASTROSCOPE
Generic NameTRAY, SURGICAL, INSTRUMENT
Product CodeFSM
Date Received2020-01-03
Returned To Mfg2019-10-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ENDOSCOPY
Manufacturer Address5900 OPTICAL COURT SAN JOSE CA 95138 US 95138


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-03

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