MAUDE Adverse Event Report: MEDIVATORS INC. SCOPE BUDDY PLUS; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Model Number SPB-1000

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

Manual cleaning device in reprocessing room 1 noted to have cracked "detergent out" connection at luer lock but not broken yet.

• Brand Name: SCOPE BUDDY PLUS
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 12099164
• MDR Text Key: 259394341
• Report Number: 12099164
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

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: SPB-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1