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

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Date 10/24/2023

Event Type  malfunction  

Event Description

The user facility reported rapicide pa part a disinfectant splashed an employee from their dsd edge aer after opening the drawer to the unit.The employee was not wearing proper ppe at the time of the event.The employee sought medical attention.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found the cap to the rapicide pa part a had split resulting in the reported event.The technician replaced the damaged cap, tested the unit, confirmed it to be operating according to specification, and returned it to service.The dsd edge aer instructions for use (pg.30) states the following "warning! avoid possible chemical burns.Always wear personal protective equipment (gloves, goggles) when handling disinfectant." steris will counsel user facility personnel on the proper use and operation of the unit, specifically wearing proper ppe.No additional issues noted.

Manufacturer Narrative

Steris performed in-service training with user facility personnel on the proper use and operation of the dsd edge aer, specifically, proper ppe use and disposal when changing the rapicide pa part a disinfectant.No additional issues noted.

• 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: 18161597
• MDR Text Key: 328510981
• Report Number: 2150060-2023-00048
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/17/2023

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: 10/24/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2014
• 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