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

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2014

Event Type  malfunction  

Manufacturer Narrative

There were no reported injuries associated with ths event.While conducting the quarterly preventative maintenance, the third party service representative was functionally checking the system and it was noted that the ultrasonics were not functioning.The service technician did not report this incident to custom ultrasonics until (b)(6) 2015.The reported symptom was attributed to a failed solder connection to the neutral connection of the 24 pin connector inside the relay box, where it is soldered into a common neutral or ground buss there had been a broken solder connection and was not completing the circuit for the ut generator board and thus causing it to be inoperable.The authorized third party service technician re-soldered the connection on the back side of the 24 pin connector located inside the relay box, then verified continuity of the circuit, operationally tested the ut generator board and finally operationally tested the machine (see printout for process (b)(4)).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 bio burden 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, the service technician noticed that the ultrasonic function was not working.The service technician did not notify custom ultrasonics of this event until (b)(6) 2014.

• 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: 4987918
• MDR Text Key: 23864112
• Report Number: 3007082252-2015-00001
• 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,health
• Reporter Occupation: Nurse
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• 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: 01/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2009
• 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