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

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem Unspecified Infection (1930)

Event Date 10/04/2013

Event Type  Injury  

Manufacturer Narrative

Due to time line associated with this event, the device has not yet been evaluated. Custom ultrasonics inc scheduled and will dispatch service technicians to the facility on (b)(6) and (b)(6) to investigate this incident. A follow up report will be provided upon completion. Custom ultrasonics inc is reporting this event with an abundance of caution.

Event Description

The customer reported that signs of carbapenem resistant enterobacteriacea-e. Coli metallo beta lactamase were found on two of the four pentax model ed 3490tk endoscope used at their facility. This was confirmed by testing at the center for disease control. The customer does not know how the incident occurred. They found several patients over a period of time with this organism and was able to trace it back to the scope used by their facility. The facility tested the system 83 plus for this organism, the results were negative. Advocate lutheran hospital notified 131 people of the incident, to date, 20 people tested positive, 9 patients experienced infection of some sort attributed to the exposure of this organism.

• Brand Name: SYSTEM 83 PLUS
• Type of Device: ENDOSCOPE WASHER-DISINFECTOR
• Manufacturer (Section D): CUSTOM ULTRASONICS INC.; ivyland PA
• Manufacturer Contact: 144 railroad dr.; ivyland, PA 18974 ; 2153641798
• MDR Report Key: 3417713
• MDR Text Key: 11155654
• Report Number: 2523209-2013-00013
• Device Sequence Number: 1
• Product Code: KOG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Other Device ID Number: EQ 4357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 10/11/2013 Patient Sequence Number: 1