IPAS EASYGRIP CANNULA 8MM
Received Dec 17, 2018 · Event occurred Nov 9, 2018
Report MW5082219 · MDR key 8175534
Device
Generic name
Catheter, Ventricular, General & Plastic Surgery
Manufacturer
Pacific Hospital Supply Co., LtdModel number
SR8-SULot number
180603
Product problems
- Break
- Detachment of Device or Device Component
Patient
39 YR
- Hematoma
- Uterine Perforation
- Foreign Body In Patient
- Hematoma
- Uterine Perforation
- Foreign Body In Patient
Narrative
Description of Event or Problem
PATIENT WAS SCHEDULED FOR A SUCTION D & C. DUE TO NATIONAL BACK ORDER/SHORTAGE OF THE REGULAR SUCTION D & C TUBING (FOR THE D & C MACHINE) THE PHYSICIANS HAVE TO USE THE MANUAL VACUUM ASPIRATOR AND CURETTES THAT GO WITH THE ASPIRATOR. DURING THIS CASE THE TIP OF THE CURETTE CANNULA BROKE OFF AND WAS NOT ABLE TO BE FOUND. THE SURGEON THEN DID A HYSTEROSCOPY AND COULD NOT FIND THE MISSING TIP. ANOTHER SURGEON DECIDED HE WOULD DO A LAPAROSCOPY TO LOOK FOR THE MISSING TIP AND LOOK FOR UTERINE PERFORATION. THE LAPAROSCOPY WAS STARTED AND IT WAS FOUND THAT THERE WAS A UTERINE PERFORATION AND A HEMATOMA. THE BROKEN TIP WAS NOT FOUND. THE SURGEON DECIDED TO ADMIT THE PATIENT FOR OBSERVATION.