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

Device Problems Device Maintenance Issue (1379); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

There are no patient injuries associated with this event.The reported symptom was attributed to a short of q5, q6, and q7, mosfet switches found on the ultrasonic generator (500 w) board, p/n 12008, which caused the fuse to open, rendering the board inoperable.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 (b)(4) 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 preventive maintenance, it was discovered that the ultrasonics were not functioning.

• 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: 5055768
• MDR Text Key: 25887216
• Report Number: 3007082252-2015-00011
• 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: Service Personnel
• Type of Report: Initial
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• 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?: No
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2010
• 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