MAUDE Adverse Event Report: MEDIVATOR MEDIVATOR ADVANTAGE PLUS ENDOSCOPE

Model Number ADVANTAGE PLUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Block (hook-ups) used for reprocessing of scopes on the medivator advantage plus is able to be modified easily by end user.

• Brand Name: MEDIVATOR ADVANTAGE PLUS ENDOSCOPE
• Type of Device: MEDIVATOR ADVANTAGE PLUS ENDOSCOPE
• Manufacturer (Section D): MEDIVATOR; minneapolis MN
• MDR Report Key: 6543641
• MDR Text Key: 76160972
• Report Number: MW5069556
• Device Sequence Number: 2
• Product Code: FEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/02/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ADVANTAGE PLUS
• Device Lot Number: 687301
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1