SPY-PHI DRUG DRAPE KIT
Received Oct 14, 2019 · Event occurred Sep 18, 2019
Report 3012345110-2019-00009 · MDR key 9188766
Device
Generic name
Cover, Barrier, Protective
Manufacturer
Stryker Endoscopy-san JoseCatalog number
HH9006
Lot number
1906241
Product problems
- Delivered as Unsterile Product
- Structural Problem
- Delivered as Unsterile Product
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ALLEGED FAILURE: "DRAPE ISN'T SEALED COMPLETELY" PROBABLE ROOT CAUSE/S: REPORTED ISSUE IS LIKELY DUE TO A FAILURE OF THE BOTTOM POUCH SEAL. THIS SEAL IS APPLIED IN-HOUSE BY DRAPE OEM PREMIER GUARD AND OEM INVESTIGATION IS ONGOING TO DETERMINE ROOT CAUSE. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem
IT WAS REPORTED THAT THE STERILE DRAPE WAS NOT SEALED COMPLETELY. NO ADVERSE CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT THE STERILE DRAPE WAS NOT SEALED COMPLETELY. NO ADVERSE CONSEQUENCES WERE REPORTED.