FDA Adverse Event Malfunction Summary report: N

STEALTH KERRISON

MDR report key: 7062802 · Received November 28, 2017

Report

Report Number: 7062802
Event Type: Malfunction
Date Received: November 28, 2017
Date of Event: August 22, 2017
Report Date: November 16, 2017
Manufacturer: BOSS INSTRUMENTS, LTD./STEALTH SURGICAL, LLC.
Product Code: HAE
Product Problem: Yes
Report Source: User Facility report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 1

IN LIGHT OF TRACKING AND TRENDING FOR DEBRIS ON STERILE INSTRUMENTS, IT WAS NOTED THAT THE STEALTH KERRISON'S WERE FOUND WITH BIOBURDEN AFTER STERILIZATION ON MULTIPLE OCCASIONS. SEVERAL TIMES PER WEEK WE HAD AN OUTSIDE VENDOR TO COME AND TAKE APART THE KERRISONS FOR STERILIZATION AND FOUND COPIOUS BONE FRAGMENTS AND BIOBURDEN INSIDE THE INSTRUMENTS. OUR PROCESS AT THAT TIME WOULD BE TO STERILIZE THESE INSTRUMENTS PER MANUFACTURERS GUIDELINES IN BETWEEN THE OUTSIDE VENDOR STERILIZATIONS. THE AMOUNT OF BIOBURDEN LEFT INSIDE THESE KERRISONS WAS UNACCEPTABLE AND WE STOPPED USING THEM. WE TRANSITIONED TO THE BLACK KERRISON'S THAT WERE NOT REQUIRED TO TAKE APART TO CLEAN. THESE BLACK KERRISONS WERE NOT SAFE TO USE. WE HAD SEVERAL COMPLAINTS FROM SURGEONS THAT THEY WERE DANGEROUS, AND HARD TO USE. WE REVERTED BACK TO THE OLD KERRISON'S AND PUT A PLAN IN PLACE THAT WE WOULD NOT UTILIZE THE INSTRUMENTATION UNTIL THE OUTSIDE VENDOR HAD TAKEN THEM APART TO STERILIZE THEM COMPLETELY BETWEEN EACH CASE. MANUFACTURER RESPONSE FOR KERRISON, STEALTH KERRISON (PER SITE REPORTER) ====================== THE DIRECTOR OF STERILE PROCESSING HAS BEEN IN CONTACT WITH THE MANUFACTURER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
842447	STEALTH KERRISON	RONGEUR, MANUAL	HAE	BOSS INSTRUMENTS, LTD./STEALTH SURGICAL, LLC.	SS6995, SS6994, SS6993, AND SS6996

Patients

Seq	Age	Sex	Outcome	Treatment
1