STRYKEFLOW2 WITHOUT TIP (6BX)
Received Jul 28, 2006 · Event occurred Jul 1, 2006
Report 2648666-2006-00034 · MDR key 753613
Device
Generic name
Suction/irrigation Device
Manufacturer
Stryker Endoscopy Puerto RicoModel number
*Catalog number
0250070500
Lot number
06052FG2
Product problems
- Battery failure
- Corroded
- Fluid/Blood Leak
- Spillage, accidental
Patient
UNKNOWN
- Skin Irritation
Narrative
Description of Event or Problem
THE STRYKEFLOW SUCTION IRRIGATION DEVICE WAS LEAKING BROWN FLUID FROM THE BATTERY PACK - SOME OF THIS FLUID SPLASHED ONTO THE RN'S CLOTHES, WHICH STARTED TO IRRITATE HER SKIN. THE DEVICE WAS REMOVED FROM THE PROCEDURE AND ONE OF THE NURSES OPENED THE BATTERY PACK AND THE BATTERIES INSIDE APPEARED CORRODED. NO HARM WAS DONE TO THE PT.
Additional Manufacturer Narrative
DEVICE IS CURRENTLY BEING SHIPPED OVERSEAS AND HAS NOT REACHED OUR SITE FOR INVESTIGATION. WHEN REC'D, A F/U REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.