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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Complaint, Ill-Defined (2331)

Event Type  Death  

Manufacturer Narrative

Currently it is denied that the system 83 plus device may have caused or contributed to the adverse event as alleged in the legal documents.

Event Description

Adverse event solely alleged in legal documents.

Manufacturer Narrative

This matter and any investigation related to the same is officially closed.The complaint only arose solely out of allegations in lawsuit and this lawsuit has been resolved with absolutely no finding of liability or wrongdoing on behalf of custom ultrasonics, inc.

• Brand Name: SYSTEM 83 PLUS
• Type of Device: ENDOSCOPE WASHER DISINFECTOR
• Manufacturer (Section D): CUSTON ULTRASONICS INC.; 144 railroad drive; ivyland PA 18974
• Manufacturer Contact: elizabeth lazaro ; 144 railroad drive; ivyland, PA 18974 ; 2153641477
• MDR Report Key: 5551642
• MDR Text Key: 41994484
• Report Number: 3007082252-2016-00013
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death