MAUDE Adverse Event Report: MEDIVATORS INC. ENDOSCOPE WASHER; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Model Number DSD EDGE

Device Problem Lack of Maintenance Documentation or Guidelines (2971)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2023

Event Type  malfunction  

Event Description

Original equipment manufacturer (oem) unable to complete preventative maintenance (pm) on one dsd edge per oem schedule due to back ordered pm parts.Site has safety and regulatory concern due to missed maintenance for device that sterilized high risk instrument and equipment.

• Brand Name: ENDOSCOPE WASHER
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS INC.
• MDR Report Key: 16984190
• MDR Text Key: 315857683
• Report Number: MW5117765
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DSD EDGE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other