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 07/29/2022

Event Type  malfunction  

Manufacturer Narrative

Contrary to the reported event stated in the medwatch, the three dsd edge automated endoscope reprocessors are not serviced or maintained by steris.All three dsd edge endoscope reprocessors subject of the reported event were manufactured in 2011 and are 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 6/10/2022 to have preventive maintenance performed on three of their dsd edge automated endoscope reprocessors (serial numbers (b)(4)).Preventive maintenance activities for units (b)(4) and (b)(4) were completed on 8/30/2022 and 9/2/2022, respectively.In-between the service request activity placed by the user facility on 6/10/2022 and the completion of the preventive maintenance activities on 8/30/2022 and 9/2/2022, user facility personnel continued to use their dsd edge endoscope reprocessors as no issues were noted with the function or operation of the devices.Preventive maintenance for unit (b)(4) is yet to be completed due to scheduling conflicts with the user facility.Once the user facility confirms a date with the steris service technician, steris will complete the preventive maintenance activity.The unit remains in service as there are no issues with the function or operation of the device.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.

Event Description

The user facility reported via medwatch (mw5111220) that preventive maintenance (pm) on three medivators dsd edge units was unable to be completed due to pm parts being on backorder.

Manufacturer Narrative

Preventive maintenance activities for unit (b)(4) were completed on 9/27/2022.

• 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 n; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 15459192
• MDR Text Key: 304706520
• Report Number: 2150060-2022-00038
• 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,Followup
• Report Date: 09/20/2022

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: 08/22/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 09/30/2022
• 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