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

Model Number 1-2-510.003

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/13/2022

Event Type  malfunction  

Event Description

The user facility reported via medwatch report (mw5113815) that preventive maintenance (pm) on two of their advantage plus automated endoscope reprocessors was unable to be completed due to pm parts being on backorder.

Manufacturer Narrative

The advantage plus automated endoscope reprocessors are not serviced or maintained by steris.Prior to receipt of the medwatch report, steris has not received requests for service for the subject advantage plus automated endoscope reprocessors.Steris is working with the customer to address their need for service.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 policies and procedures.A follow-up mdr will be submitted when additional information becomes available.

Manufacturer Narrative

Steris contacted the customer to address their need for service.The customer stated that they received the pm packs that were on temporary backorder and elected to perform the maintenance themselves on the advantage plus automated endoscope reprocessors subject of the reported event.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 n; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 16214408
• MDR Text Key: 308013856
• Report Number: 2150060-2023-00007
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• 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: 01/20/2023

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 Model Number: 1-2-510.003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/20/2023
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2017
• 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