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

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Adverse event as alleged solely in legal documents.

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: 5522600
• MDR Text Key: 41040313
• Report Number: 3007082252-2016-00006
• 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: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• 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
• Date Manufacturer Received: 02/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1