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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION STRYKEFLOW; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER CORPORATION STRYKEFLOW; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 0250070500
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2017
Event Type  malfunction  
Event Description
The suction irrigator was attached to a 3000 ml bag of normal saline.It started leaking into the battery compartment.It was a fire hazard since the batteries were hot after removing it from the compartment.The actual saline bag was not leaking.However, it was noticed that the fluid from the bag was leaking into the battery compartment of suction irrigator so the suction irrigator was faulty.The bag itself had no holes and was okay.Suction irrigators are manufactured by stryker company.It is a one-time use (disposable) so clinical engineering was not notified.
 
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Brand Name
STRYKEFLOW
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER CORPORATION
5900 optical ct.
san jose CA 95138
MDR Report Key6610471
MDR Text Key76628416
Report Number6610471
Device Sequence Number1
Product Code NLM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number0250070500
Device Catalogue Number250-070-500
Device Lot Number17059FG2
Other Device ID NumberREF 250-070-500
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/01/2017
Event Location Hospital
Date Report to Manufacturer06/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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