inforMED
MalfunctionFCZ

SEECLEAR XCL

Received Mar 28, 2014 · Event occurred Mar 3, 2014

Report 3732816 · MDR key 3732816

Device

Generic name

Tube, Smoke Removal, Endoscopic

Model number

*

Catalog number

SC082500

Lot number

147344

Product problems

  • Device Operates Differently Than Expected

Patient

71 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH ROBOTIC ASSISTED AND BILATERAL SALPINGO-OOPHORECTOMY, CYSTOSCOPY. DURING THE PROCEDURE THE SMOKE EVACUATION TUBING HAD SUB-OPTIMAL SMOKE EVACUATION, DELAYING THE PROCEDURE UNTIL SMOKE CLEARED FROM THE ABDOMINAL CAVITY. PER STAFF, "IT TOOK A LONG TIME AND THE PRODUCT DOES NOT WORK WELL". UNSURE OF EXACT AMOUNT OF TIME. WE HAVE HAD REPEATED ISSUES WITH THE PRODUCT ACCORDING TO OUR STAFF. THERE WAS NO HARM TO THE PATIENT.