MalfunctionFHO
SURGINEEDLE
Received Aug 10, 2021 · Event occurred Jul 10, 2021
Report 3003139373-2021-00120 · MDR key 12304889
Device
Generic name
Pneumoperitoneum Needle
Manufacturer
Celestica De Monterrey S.a. De C.v.Model number
172015Catalog number
172015
Lot number
T0H002X
Product problems
- Break
- Break
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THERE WAS A BREAK IN THE PLASTIC PART OF THE NEEDLE, WHICH IS ATTACHED TO THE GAS SYSTEM. IT COULD NOT HAVE BROKEN BECAUSE IT IS USED TO USE.