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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

The user facility reported that an employee loaded a scope into their dsd edge endoscope reprocessing system and rapicide "sprayed" out into the room in which the unit is located.It is unknown if employees present in the room sought or received medical treatment.

Manufacturer Narrative

The employee subject of the reported event had loaded the scope with the distal tip angled out of the basin.When the cycle was initiated, this caused the reported event to occur.The employee did not load the scope properly as they left the scope tip outside of the floating lid.When the lid was closed on the unit, the distal tip being outside of the floating lid may have caused the reported event to occur.The operator manual states (pg.37), "ensure the distal end is not pointing upward toward the floating lid.Place the floating lid on the basin.Verify the endoscope or hookup does not protrude from the basin or contact the floating basin lid (the endoscope must be completely submerged when basin is filled).Close the reprocessor lid." steris offered in-service training on the proper use and operation of the dsd edge endoscope reprocessing system specifically, the proper loading procedure for scopes.A steris service technician inspected the dsd edge endoscope reprocessing system and confirmed the unit to be operating properly.No issues were noted with the function or operation and the unit was returned to service.No additional issues have been reported.

Manufacturer Narrative

Steris offered in-service training on the proper use and operation of the dsd edge endoscope reprocessing system specifically, the proper loading procedure for scopes however, the user facility declined.No additional issues have been reported.

• 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 north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 18904140
• MDR Text Key: 337690506
• Report Number: 2150060-2024-00019
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2013
• 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