MAUDE Adverse Event Report: CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS 2; ENDOSCOPE WASHER - DISINFECTOR

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 03/03/2016

Event Type  malfunction  

Manufacturer Narrative

There are no patient injuries associated with this event.The reported symptom for the returned ultrasonic generator (500 w) board was attributed to a faulty diode, on the ac input signal, within the bridge rectifier, brg1, on the ultrasonic generator (500 w) board, p/n 12008, causing the fuse to open, rendering the board inoperable.This diode is located on the ac input plus side of the bridge rectifier and its failure is likely attributed to age (16 years) and an over current condition.The loss of the ultrasonic generator does not, of and by itself, result in an endoscopic high level disinfection process failure that does not render a microbiologically safe product or present any additional risks for reuse given the nature of the pre-cleaning labeling instructions and high-level disinfection.Given the nature of endoscope pre-processing and high-level disinfection based on sgna guidelines, either the presence or absence of ultrasonics should still result is an endoscope that has had its bioburden reduced to an acceptable level.It is concluded that there is no reasonable likelihood that an endoscope processed in the absence of the ultrasound will present any additional risks.

Event Description

During a scheduled preventive maintenance visit the technician noticed the ultrasonic function was not working.

• Brand Name: SYSTEM 83 PLUS 2
• Type of Device: ENDOSCOPE WASHER - DISINFECTOR
• Manufacturer (Section D): CUSTOM ULTRASONICS INC.; 144 railroad drive; ivyland PA 18974
• Manufacturer Contact: elizabeth lazaro ; 144 railroad drive; ivyland, PA 18974 ; 2153641477
• MDR Report Key: 5520141
• MDR Text Key: 41256684
• Report Number: 3007082252-2016-00005
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1