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

Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

There are no reported injuries associated with this event.The reported symptom relating a white residue noted in the system hld reservoir is likely attributed to the facility water quality (hard water) and interaction with metricide opa plus which can create precipitates as indicated in the hld manufacturer's product labeling.The reported symptom relating to a failure of the ultrasonics not functioning in bay 1 is attributed to liquid ingress onto the transducer crystal/nose and tail pc assembly, p/n 12061, causing a shorting condition that eventually led to the failure of the ultrasonic generator (500 w) board, p/n 12008, date code october 04, 2000.The cause for the liquid ingress could not be determined.

Event Description

During use, a white residue was noted in the system hld reservoir.The customer is using cidex opa for hld and tergal 800 for detergent.Additionally, it was noted by the facility biomed during a function test of the machine to verify performance that the ultrasonics in bay 1 were not functioning as intended.Bay 2 ultrasonics are functioning normally.Scopes being processed at the time were processed alternatively.

• Brand Name: SYSTEM 83 PLUS 9
• Type of Device: ENDOSCOPE WASHER AND DISINFECTOR
• Manufacturer (Section D): CUSTOM ULTRASONICS INC.; 144 railroad drive; ivland PA 18974
• Manufacturer Contact: elizabeth lazaro ; 144 railroad drive; ivyland, PA 18974 ; 2153641477
• MDR Report Key: 5097728
• MDR Text Key: 26773712
• Report Number: 3007082252-2015-00014
• 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: Biomedical Engineer
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• 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: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2000
• 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