inforMED
MalfunctionFHO

SURGINEEDLE

Received Jun 20, 2018 · Event occurred May 24, 2018

Report 1219930-2018-03239 · MDR key 7620528

Device

Generic name

Pneumoperitoneum Needle

Model number

172015

Catalog number

172015

Product problems

  • Detachment Of Device Component
  • Detachment Of Device Component

Patient

59 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

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 CHOLECYSTECTOMY, THE VALVE OF THE DEVICE DISLODGED AND FELL INSIDE THE PATIENT¿S CAVITY. IT WAS LOCATED AND REMOVED AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.