MAUDE Adverse Event Report: MEDIVATORS INC ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM

Device Problems Device Difficult to Setup or Prepare (1487); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

The user facility reported via medwatch report # 4400480000-2023-8027 that, "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." no report of injury.

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Manufacturer Narrative

A steris service technician contacted the user facility to obtain additional information regarding the reported event.The steris technician discussed the reported event with the facility's nurse manager/surgical services.The nurse manager stated that they only had one ercp scope and one hookup for the scope and that the hookup was not operating properly.The user facility contacted steris and ordered a new hookup.Once the hookup was received, the user facility replaced the hookup subject of the reported event with the new hookup and returned the advantage plus endoscope reprocessing system to service.The hookup subject of the reported event was discarded by user facility personnel and is not available for evaluation.Without the return or evaluation of the hookup, a root cause cannot be determined.No additional issues have been reported.

• Brand Name: ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM
• Type of Device: ENDOSCOPE REPROCESSING SYSTEM
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 18862803
• MDR Text Key: 337795389
• Report Number: 2150060-2024-00018
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964066726
• UDI-Public: 00677964066726
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1