MAUDE Adverse Event Report: MEDIVATORS, INC. DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR

Device Problems Leak/Splash (1354); Insufficient Information (3190)

Patient Problem Aspiration/Inhalation (1725)

Event Date 10/05/2022

Event Type  malfunction  

Event Description

The user facility reported that their dsd edge automated endoscope reprocessor was leaking subsequently causing an employee to experience inhalation/irritation from rapicide pa.

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Manufacturer Narrative

Through follow-up, the user facility stated that the employee subject of the reported event went home for the remainder of the day following the event.The user facility confirmed that the employee has returned to work.Following the reported event, a steris service technician arrived onsite to inspect the unit.The user facility stated that the chemistry caps were damaged which may have contributed to the reported event.User facility personnel had replaced the chemistry caps and placed the unit back into service.While onsite, the steris service technician confirmed the unit was operating properly.

• 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: 15734772
• MDR Text Key: 304878307
• Report Number: 2150060-2022-00048
• 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: 11/04/2022

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: 10/05/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 10/05/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2015
• 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