MAUDE Adverse Event Report: MEDIVATORS INC DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Use of Device Problem (1670)

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

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

A steris infection prevention consultant was informed that a user facility employee used metrex empower detergent to process a scope in their dsd-201 instead of an appropriate high-level disinfectant (hld) which is not in accordance with the instructions for use.Metrex empower is a pre-cleaner used on medical devices prior to hld.Based on discussion with user facility personnel, this issue was isolated to the one patient subject of the event.The dsd-201 automated endoscope reprocessor user manual states (6), "the dsd-201 reprocessor is intended to be used to wash, high-level disinfect and rinse endoscopes and related accessories between uses.It is intended to be used with a legally marketed high-level disinfectant solution." the user manual further states (8), "disinfectant solution select a low-foaming, high-level disinfectant specifically manufactured for high-level medical instrument disinfection.The product must be capable of destroying m.Tuberculosis." additionally, user facility personnel should be testing the hld for potency before each reprocessing cycle.The operator manual states (61), "warning! never use disinfectant that is below acceptable mrc level, even if the reuse date is unexpired." following the reported event, the metrex empower detergent was emptied from the dsd-201 and then refilled with the appropriate hld.The dsd-201 automated endoscope reprocessor was confirmed to be operational after the correction was made and the device was returned to service.The steris infection prevention consultant counseled user facility personnel on the proper use and operation of the dsd-201, specifically using the proper high-level disinfectant.Medivators is not aware of any adverse clinical event associated with this incident and is filing this mdr because the high-level disinfection of devices processed in the dsd-201 automated endosceop reprocessor cannot be guaranteed unless devices are processed in accordance with medivators instructions for processing and use.No additional issues have been reported.

Event Description

The user facility reported that they were using a detergent instead of a high-level disinfectant when processing a scope in their dsd-201 automated endoscope reprocessor.The scope was subsequently used on a patient.No report of injury.

• Brand Name: DSD-201 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 north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 17510169
• MDR Text Key: 321715608
• Report Number: 2150060-2023-00039
• 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: 08/11/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/11/2023
• 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