MAUDE Adverse Event Report: MEDIVATORS INC. ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Lot Number 574862

Patient Problems Abdominal Pain (1685); Gastritis (1874)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

The patient needed an endoscopic retrograde cholangiopancreatography (ercp) related to epigastric pain, gastritis without bleeding, and unspecified abdominal pain.Staff tried twice to load the advantage medivator to prepare supplies, but the machine malfunctioned and alarmed on two separate attempts resulting in inability to perform procedure.Patient was monitored over night and discharged to receive procedure at an outpatient clinic in the area.

• Brand Name: ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave north; minneapolis MN 55447
• MDR Report Key: 18676538
• MDR Text Key: 335017396
• Report Number: 18676538
• 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: 12/19/2023

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 Lot Number: 574862
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White