FDA Adverse Event Other Summary report: N

CUSTOM ULTRASONIC

MDR report key: 1315772 · Received February 19, 2009

Report

Report Number: 2523209-2009-00004
Event Type: Other
Date Received: February 19, 2009
Date of Event: January 19, 2009
Report Date: February 10, 2009
Manufacturer: CUSTOM ULTRASONICS INC
Product Code: NVE
PMA / PMN Number: K983017
Report Source: Manufacturer report
Reporter Location: OR, US

Narratives

Description of Event or Problem · 1

CUSTOMER COMPLAINT RECEIVED REGARDING WRONG DISINFECTANT TYPE CALIBRATION MADE TO SYSTEM 83 + ENDOSCOPIC REPROCESSOR. INVESTIGATION OF COMPLAINT REVEALED THAT CUSTOMER HAD PROVIDED WRONG DISINFECTANT TYPE WHICH LED TO THE CALIBRATION ERROR. SVC TECH WAS DISPATCHED IMMEDIATELY AND CALIBRATION ERROR WAS CORRECTED TO INDICATE THE PROPER DISINFECTANT AND PARAMETERS. ALTHOUGH UNLIKELY, THIS CONDITION CAN PUT A PT AT RISK FOR INFECTION IF THE COLONOSCOPE IS NOT IMMERSED IN THE FACILITY'S CHOICE OF DISINFECTANT SOLUTION FOR THE PRESCRIBED TIME SUGGESTED BY THE MFR. ANY SUCH INFO MUST BE ACCURATELY SUPPLIED BY FACILITY PERSONNEL AND CALIBRATED INTO THE SYSTEM 83+ AT TIME OF INITIAL INSTALLATION AND PRIOR TO USE USING THE PRESCRIBED PARAMETERS DICTATED BY THE DISINFECTANT MFR. IT IS NOT KNOWN HOW MAY PTS MAY HAVE BEEN PUT AT RISK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CUSTOM ULTRASONIC	AUTOMATED ENDOSCOPIC REPROCESSOR	NVE	CUSTOM ULTRASONICS INC	SYSTEM 83+2DTWPV19	EQ#3460

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA			OPA 14 DAY