FDA Adverse Event Malfunction Summary report: N

GE HEALTHCARE IC5-9-D

MDR report key: 6331515 · Received February 13, 2017

Report

Report Number
MW5067894
Event Type
Malfunction
Date Received
February 13, 2017
Report Date
February 13, 2017
Manufacturer
GE HEALTHCARE
Product Code
ITX
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MO, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

UPON CLEANING ONE OF OUR GE ENDOCAVITARY PROBES AFTER A PROSTATE BIOPSY, BLOOD HAD COLLECTED WHERE THE HANDLE MEETS THE PROBE. IT HAS WHAT LOOKS LIKE A RING OR RIDGE ALL THE WAY AROUND THE PROBE. AFTER CLEANING THE PROBE WE INSPECTED IT UNDER A MAGNIFYING LENS AND COULD SEE PIECES OF WHAT LOOKS LIKE A SEAL IS MISSING ALL ROUND THIS RING. WE TOOK THE PROBE OUT OF SERVICE, CONTACTED OUR RADIOLOGY DEPARTMENT, INFECTION CONTROL AND THE SPECIALTY CLINIC NURSE MANAGER. I CONTACTED GE AND BEGAN THE TASK OF GETTING SOMEONE TO HELP ME. AFTER SPEAKING TO SEVERAL PEOPLE AND HAVING THEM TELL ME THIS WAS NORMAL I INSISTED THAT THEY HELP ME RESOLVE THIS ISSUE. FINALLY I WAS SENT TO OUR GE SERVICE TECH (B)(4). WITH THE HELP OF BIOMED, WE SENT THEM PICTURES TAKEN WITH A MICROSCOPE THEY HAVE DOWN IN BIOMED SHOP. AFTER GE ACKNOWLEDGED THIS WAS AN ISSUE THEY DECIDED TO REPLACE OUR PROBES. WE RECEIVED TWO NEW PROBES FROM GE AND UPON INSPECTION WE COULD SEE THESE PROBES HAD THE SAME ISSUE. WHEN I NOTIFIED (B)(4) AND AGAIN SENT HIM PICTURES HE THEN CAME BACK AND SAID THEY ARE GOING TO SEND TWO NEW PROBES TO ME AND I WILL LOOK AT THEM AND THEN BRING THEM TO YOU. I GOT AN EMAIL FROM (B)(4) A COUPLE DAYS LATER THAT SAID THE TWO PROBES SENT TO HIM HAD THE SAME ISSUE. IT IS IMPORTANT TO NOTE THAT THE CONCERN WITH THE SEAL AREA WAS NOT VISIBLE TO THE NAKED EYE AND THEREFORE WOULD GO UNDETECTED UNLESS THERE WAS CLOSE INSPECTION USING A MICROSCOPE. ANOTHER ISSUE WAS ALSO IDENTIFIED. A SHARP AREA WAS NOTED WHERE THE NEEDLE GUIDE ATTACHES TO THE PROBE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
110393 GE HEALTHCARE IC5-9-D GE ENDOCAVITORY PROBES ITX GE HEALTHCARE IC5-9-D
110394 GE HEALTHCARE IC5-9-D GE ENDOCAVITORY PROBES ITX GE HEALTHCARE
110395 GE HEALTHCARE GE ENDOCAVITORY PROBES ITX GE HEALTHCARE
110396 GE HEALTHCARE IC5-9-D GE ENDOCAVITORY PROBES ITX GE HEALTHCARE

Patients

Seq Age Sex Outcome Treatment
1