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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

There are no reported patient injuries associated with this event.The reported symptom was reproduced and the failure of the ultrasonic generator (500 w) board, date code june 27, 2005, p/n 12008, is attributed to liquid ingress of multiple components.

Event Description

The ultrasonic feature of the system 83 plus was not functioning properly.

• 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: 6239022
• MDR Text Key: 64768813
• Report Number: 3007082252-2017-00001
• 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: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• 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: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2005
• 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