MAUDE Adverse Event Report: CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS 9; ENDOSCOPE WASHER DISINFECTOR

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

There are no reported injuries associated with this event.The reported symptom relating to a failure of the ultrasonics not functioning is attributed to liquid ingress onto the ultrasonic generator (500 w) board, p/n 12008, date code november 19, 2009 and the transducer crystal/nose and tail pc assembly, p/n 12061, causing a shorting condition that led to the failure.The liquid ingress was caused by the leak found during the preventative maintenance between the return and the high level disinfectant reservoir.

Event Description

While on site for a scheduled preventative maintenance, it was noticed that the ultrasonics were not functioning, as well as, a leak was noted dripping onto the ultrasonic generator enclosure.

• Brand Name: SYSTEM 83 PLUS 9
• 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: 5105054
• MDR Text Key: 26963646
• Report Number: 3007082252-2015-00013
• 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,user f
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• 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?: Yes
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2010
• 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