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

Device Problems Improper or Incorrect Procedure or Method (2017); Device Disinfection Or Sterilization Issue (2909); Device Operates Differently Than Expected (2913)

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

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

There are no reported injuries associated with this event.The reported symptom relating to during use, the process chamber will fill with water but does not go any further than the wash / disinfect cycle was attributed to the basin drain cup, (p/n 11013); it's positioning could have contributed to an air pocket that may not allow the liquid to be properly be detected resulting in a safety float error.The drain cup was re-aligned and the system performed as intended.The reported issue relating to 783 wash only (f6) cycles being performed since (b)(6) 2014, cannot be clearly determined as follow up calls have gone unanswered; however, it is attributed to user error in not following the intended use of the device.Custom ultrasonics is reporting this event out of an abundance of caution.

Event Description

On (b)(6) 2015, the customer called requesting service due to during use, the process chamber will fill with water but does not go any further than the wash / disinfect cycle.Scopes being processed at the time were processed alternatively.On-site inspection on (b)(6) 2015 by a custom ultrasonics service technicians found after inspection of the system log, the customer may have performed wash and rinse cycles only during processing of scopes.There has been no report of patient injury; however, the customer has not been responsive to inquiries.

• Brand Name: SYSTEM 83 PLUS 2
• Type of Device: 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: 5261815
• MDR Text Key: 32770032
• Report Number: 3007082252-2015-00015
• 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: Physician
• Type of Report: Initial
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2002
• 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