FDA Adverse Event Malfunction Summary report: N

NEOGUARD SURGI-BOOT

MDR report key: 1707625 · Received May 27, 2010

Report

Report Number
1707625
Event Type
Malfunction
Date Received
May 27, 2010
Date of Event
April 26, 2010
Report Date
May 26, 2010
Manufacturer
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Code
ITX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

TOWARDS THE END OF THE SURGICAL PROCEDURE, SURGEON REQUESTED AN INTRAOPERATIVE ULTRASOUND OF THE PATIENT'S LEFT RENAL VEIN AND VENA CAVA. AN ULTRASOUND TECH CAME TO THE OR FROM THE DIAGNOSTIC VASCULAR LABORATORY (DVU) WITH THEIR ULTRASOUND MACHINE. SURGEON WAS GIVEN THE STERILE PROBE COVER (#1) TO PLACE OVER THE ULTRASOUND PROBE. THE COVER WAS PLACED, AND THE PROBE USED INSIDE THE WOUND. AFTER THE PROBE WAS USED, SURGEON DECIDED TO REVISE A PART OF THE BYPASS AND THEN DO ANOTHER ULTRASOUND. THE PROBE WAS REMOVED FROM THE WOUND AND SET ON THE STERILE FIELD. IT WAS AT THIS TIME THAT THE SCRUB NURSE NOTICED THE TIP OF THE PROBE WAS THROUGH THE STERILE DRAPE AND HAD CONTAMINATED THE FIELD. THE PROBE WAS REMOVED FROM THE FIELD, THE TORN COVER (#1) WAS REMOVED. NURSE IMMEDIATELY OPENED A NEW COVER (#2) TO THE FIELD. THE SCRUB NURSE WAS PREPARING TO PLACE THE NEW COVER ON THE PROBE WHEN SHE NOTICED THAT THERE WAS A SLIT IN THE SECOND COVER. SHE INSPECTED THIS FURTHER AND THE ENTIRE TIP OF THE COVER CAME OFF IN HER HAND. NURSE HANDED HER A THIRD COVER THAT DIDN'T HAVE ANY FLAWS AND WE WERE ABLE TO USE THAT FOR THE CASE. THE AREA OF THE SURGICAL FIELD THAT WAS KNOWN TO BE CONTAMINATED FROM THE TIP OF THE PROBE WAS ISOLATED AND COVERED WITH AN IOBAN. THE PACKAGING FROM PRODUCTS 1, 2 AND 3 WERE SAVED. THE ACTUAL COVER (#2) THAT WAS DEFECTIVE AND NOT USED IN THE PATIENT WAS ALSO SAVED FOR REVIEW.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NEOGUARD SURGI-BOOT ULTRASOUND TRANSDUCER COVER, INTRAOPERATIVE ITX CIVCO MEDICAL INSTRUMENTS CO., INC. * M400690

Patients

Seq Age Sex Outcome Treatment
1 18 YR