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 11/30/2022

Event Type  malfunction  

Event Description

The user facility reported via medwatch (mw5113594) that preventive maintenance (pm) on their dsd edge automated endoscope reprocessor was unable to be completed due to pm parts being on backorder and staff availability.

Manufacturer Narrative

Contrary to the reported event stated in the medwatch, the dsd edge automated endoscope reprocessor is not serviced or maintained by steris.The dsd edge endoscope reprocessor subject of the reported event was manufactured in 2016 and is no longer under the warranty period.The user facility is responsible for service, routine maintenance, and all preventive maintenance activities for the equipment.The user facility contacted steris via a service request on 9/6/2022 to have preventive maintenance performed on their dsd edge automated endoscope reprocessor.Preventive maintenance activities were completed on 11/10/2022.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.No additional issues have been reported.

• 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: 16104995
• MDR Text Key: 308013411
• Report Number: 2150060-2023-00001
• 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: 01/05/2023

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 Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• 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