MAUDE Adverse Event Report: MEDIVATORS INC DSD 201 ENDOSCOPE REPROCESSING SYSTEM

Device Problem Leak/Splash (1354)

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

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

Steris has contacted the customer for additional information regarding the reported event.To date, we have not received a response from the customer.A follow-up mdr will be submitted should additional information become available.A steris service technician offered to perform an inspection of the unit; however, the user facility declined and cancelled the service request.The unit was installed in 2010 and is not under steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities.The medivators dsd-201 user manual gives the following instructions to the user, "proper maintenance will ensure effective disinfection and prolong the life of the reprocessor." in addition, it states "gfci is tripped.Locate the gfci on the inside back wall of the reprocessor.Press the reset button on the gfci.If the gfci cannot be reset, contact your technical service representative.".

Event Description

The user facility reported an internal water leak from their dsd 201 tripped the gfci.User facility personnel further stated their outlet sparked when plugging in the unit.No report of injury.

• Brand Name: DSD 201 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 ; 4403927453
• MDR Report Key: 19088661
• MDR Text Key: 340699900
• Report Number: 2150060-2024-00025
• 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: 04/11/2024

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: 03/13/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2010
• 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