MAUDE Adverse Event Report: MEDIVATORS INC DSD EDGE ENDOSCOPE REPROCESSING SYSTEM

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2023

Event Type  malfunction  

Event Description

The user facility reported via medwatch (mw5117765) that preventive maintenance (pm) on their dsd edge automated endoscope reprocessor (aer) was unable to be completed due to pm parts being on backorder.

Manufacturer Narrative

The user facility requested service on the subject dsd edge aer 5/11/2023.A steris service technician completed necessary service repairs 5/17/2023, tested the unit and returned it to service.During the steris service technician's visit, the user facility indicated that preventive maintenance (pm) needed to be performed on the unit the following day (5/18/2023), a billable pm service ticket was opened.That same day, the user facility elected to file medwatch (mw5117765) stating that preventive maintenance could not be completed due to parts being on backorder.However, this is a false statement and is contrary to the reported event as the service parts needed to complete the pm activity were not on backorder.Steris schedules service activities (repair and preventive maintenance) based on availability of service technicians.Pm activities are prioritized for customers on a steris service contract.The dsd edge aer at mclaren regional - bay regional medical center is not under a service contract with steris.The user facility is responsible for service and all preventive maintenance activities for the equipment.Due to the steris service technician's availability, the preventive maintenance activities for the subject dsd edge aer were scheduled and completed on 6/20/2023.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.

• Brand Name: DSD EDGE 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
• MDR Report Key: 17234783
• MDR Text Key: 318341885
• Report Number: 2150060-2023-00034
• 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: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2023

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 Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• 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