MalfunctionEFS
STRYKERFLOW2 WITHOUT TIP (6BX)
Received Oct 18, 2006 · Event occurred Sep 19, 2006
Report 2648666-2006-00046 · MDR key 910945
Device
Generic name
Suction/irrigation Device
Manufacturer
Stryker Endoscopy Puerto RicoModel number
*Catalog number
0250070500
Lot number
06230FG2
Product problems
- Replace
- Spillage, accidental
Patient
43 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PRODUCT WAS CONNECTED TO A BAG WITH NORMAL SALINE. WHEN THE SURGEON PUSHED THE BUTTON FOR IRRIGATION, THE NORMAL SALINE SPLASHED ALL OVER FROM THE BOTTOM OF THE BATTERY PART. ANOTHER NEW ONE WAS USED WITHOUT PROBLEM. THERE WAS NO INJURY OR INTERVENTION REQUIRED DUE TO THE EVENT.
Additional Manufacturer Narrative
DEVICE WAS RECEIVED AT OUR DISTRIBUTION LOCATION AND SENT TO THE MFG SITE FOR EVALUATION. ONCE COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.