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

Device Problem Microbial Contamination of Device (2303)

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

Event Date 03/13/2015

Event Type  malfunction  

Manufacturer Narrative

The reported symptom was possibly attributed to user error by either not applying alcohol injection into the scope at the completion of reprocessing in the system 83 plus, improper drying methods, or use of non-oem filters.The facility received re-inservice training regarding use of the system 83 plus washer / disinfector and storage cabinet on march 30th, 2015.At the time of this report custom ultrasonics cannot confirm if there were any patient injuries.Custom ultrasonics is reoprting this event out of an abundance of caution.

Event Description

On 03/13/2015, custom ultrasonics received a call requesting a preventative maintenance be completed.The customer also stated that a colonscope and an ercp scope were removed from a scope storage cabinet and when tested were found to produce ((b)(6) 2015 pseudomonas aeruginosa-cf160 and gif2t160, (b)(6) pseudomonas stenotrophomonas- cf160 and tjf160vf) positive cultures.Additional information was obtained on 03/23/2015: on (b)(6) 2015, cf160 and gif2t160 scopes were cultured and tested positive for pseudomonas aeruginosa in both auxiliary channel ports.Another two models, cf160 and tjf160vf, were found to be positive on (b)(6).These scopes were tested at the auxiliary channel ports (elevator channel for tjf160vf) and were positive for pseudomonas stenotrophomonas.

• 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: 4987920
• MDR Text Key: 24555387
• Report Number: 3007082252-2015-00007
• 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: 03/13/2015

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: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2007
• 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