MAUDE Adverse Event Report: MEDIVATORS, INC. DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/30/2022

Event Type  malfunction  

Event Description

The user facility reported via medwatch (mw5111841) that preventive maintenance (pm) on two medivators dsd edge units were unable to be completed due to staffing issues.No report of injury.

Manufacturer Narrative

Through follow-up with the user facility, steris confirmed that the units subject of the reported medwatch are the same units from medwatch mw5111220 that was previously submitted by the user facility on 8/22/2022.Steris filed a medical device report #2150060-2022-00038 on 9/20/2022 in response to the user facility's medwatch report (mw5111220).The medivators dsd edge units subject of the reported event received preventive maintenance activities prior to the receipt of the reported medwatch (mw5111841) and had no staffing issues.The units have remained in service with no issues reported to steris.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 AUTOMATED ENDOSCOPE REPROCESSOR
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• 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: 15638262
• MDR Text Key: 304924796
• Report Number: 2150060-2022-00043
• 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: 10/20/2022

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: 09/20/2022
• Initial Date FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2011
• 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