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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

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 dcouments.

Event Description

It is solely alleged, through legal documents, that the adverse event was death.However, it is believed the device used at this facility was not a system 83 plus device.Investigation is on-going to this extent.In addition, all liability is denied.

Manufacturer Narrative

With respect to this reported adverse event, there has been absolutely no finding of wrongdoing on the part of custom ultrasonics, inc.In addition, there has been absolutely no finding of any related functionality issues with the system 83 plus 2 and plus 9 automated endoscope reprocessor ("aer") and the aer's ability properly reprocess endoscopes.

• Brand Name: SYSTEM 83 PLUS
• Type of Device: ENDOSCOPE WASHER DISINFECTOR
• Manufacturer (Section D): CUSTOM ULTRASONICS INC.; 144 railroad drive; ivyland PA 18974
• MDR Report Key: 6443145
• MDR Text Key: 71155790
• Report Number: 3007082252-2017-00008
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• PMA/PMN Number: K983017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

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
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: 03/09/2017
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death