LAP SPONGE
Received Aug 29, 2019 · Event occurred Aug 1, 2019
Report 3010452421-2019-00001 · MDR key 8944176
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Ortho And Surgical Products Enterprises S.a.Model number
1-418NSLot number
47481307
Product problems
- Material Separation
- Material Integrity Problem
- Material Separation
- Material Integrity Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING THAT AN X-RAY DETECTABLE ELEMENT OF A LAPAROTOMY SPONGE (PART 1-418NS, LOT 47481307) WAS EXPOSED AND CAME OUT WITH MINIMAL TENSION. THE DEFECTIVE SAMPLE WAS NOT AVAILABLE FOR RETURN. HOWEVER, THE REPORTING CUSTOMER PROVIDED A PHOTO THAT CONFIRMED THE REPORTED ISSUE. THE INVESTIGATION IS ONGOING AT THIS TIME. THIS REPORT WILL BE UPDATED WHEN NEW AND CRITICAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE X-RAY DETECTABLE PIECE IS EXPOSED ON THE SIDE OF THE SPONGE. THE LONGER STRIP CAME OUT WITHOUT MINIMAL TENSION.