MalfunctionLIO
APPLIED SCIENCE ENDOCATCH BAG
Received Sep 2, 2016 · Event occurred May 31, 2016
Report MW5064613 · MDR key 5938940
Device
Generic name
Applied Science Endocatch Bag
Manufacturer
Applied MedicalModel number
CD004Lot number
1248683
Product problems
- Difficult to Open or Close
Patient
54 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING A LAPAROSCOPIC NEPHRECTOMY APPLIED SCIENCE ENDOCATCH BAG X2 DID NOT OPEN WHEN FIRED. MD HAD TO EXTEND INCISION TO MANUALLY REMOVE KIDNEY. NO PT HARM. DIAGNOSIS OR REASON FOR USE: KIDNEY DISEASE. IS THE PRODUCT COMPOUNDED? NO. IS THE PRODUCT OVER-THE-COUNTER? NO.