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

Model Number DSD Edge 120V

Device Problem Unintended Movement (3026)

Patient Problem Abrasion (1689)

Event Date 04/25/2023

Event Type  malfunction  

Event Description

The user facility reported that the lid on their dsd edge automated endoscope reprocessor (aer) contacted an employee's head subsequently causing the employee to obtain an injury.No medical treatment was sought or administered.

Manufacturer Narrative

A steris service technician inspected the dsd edge aer and found that the lid lift spring required replacement.As the lid lift spring required replacement this allowed the lid to lower subsequently causing the reported event to occur.The steris service technician replaced the lid lift spring, tested the unit, and returned it to service.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
• MDR Report Key: 16999592
• MDR Text Key: 316046138
• Report Number: 2150060-2023-00030
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• 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: 05/24/2023

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
• Device Model Number: DSD Edge 120V
• Device Catalogue Number: DSD3008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• 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