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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY STRYKEFLOW II; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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STRYKER ENDOSCOPY STRYKEFLOW II; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED Back to Search Results
Catalog Number 250-070-520
Device Problems Bent (1059); Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Date 09/30/2015
Event Type  malfunction  
Event Description
Device leaked sterile fluid onto electrical equipment and floor.(potential contamination to sterile field/patient and damage to electrical equipment.) after surveying the staff this issue has occurred in the past.In order to recreate the reported issue i connected a bag of sterile water to the identified product and applied pressure in an attempt to force a leak.A small drop appeared at the connection of the clear inflow tubing and the white쳌battery/spike housing.With a slight bend to the tubing it completely disconnected from the housing.
 
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Brand Name
STRYKEFLOW II
Type of Device
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Manufacturer (Section D)
STRYKER ENDOSCOPY
5900 optical court
san jose CA 95138
MDR Report Key5147779
MDR Text Key28149291
Report Number5147779
Device Sequence Number1
Product Code GCX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Report Date 10/08/2015,10/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2015
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Expiration Date08/01/2017
Device Catalogue Number250-070-520
Device Lot Number15220FG2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2015
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/08/2015
Device Age1 MO
Event Location Hospital
Date Report to Manufacturer10/08/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
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