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

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 11/14/2014

Event Type  malfunction  

Manufacturer Narrative

There are no injuries associated with this event.Evaluation summary: the reported symptom, in regards to the water channel error, was attributed to a failed flojet purge pump (2100-5-15a), date code july 2013, p/n 11010, and was caused by thermal damage which lead to premature failure of the pump.The reported symptom relating to the ultrasonics not performing as intended was attributed to the ultrasonic generator (500 w) board only, date code 2012, p/n 12008, and was caused by a faulty resistor.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 re-use given the nature of the pre-cleaning labeling instructions and high-level disinfection.The biomed / facility staff was provided a copy of the technical bulletin - tb-2013-004.The customer was also informed that this procedure should be carried out every morning prior to the processing of any scopes.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 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 the pre-use function test, it was noticed that the system would display a water channel error.While at facility for repair of the device, the service representative discovered that machine the ultrasonics did not function as intended.

Manufacturer Narrative

(b)(6).

• 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: 4988653
• MDR Text Key: 23912231
• Report Number: 3007082252-2014-00031
• 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: Hospital Service Technician
• Report Date: 09/04/2015

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2002
• 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