MAUDE Adverse Event Report: MEDIVATORS, INC. DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR; ENDOSCOPE REPROCESSING SYSTEM

Device Problem Use of Device Problem (1670)

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

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

User facility personnel were not preparing the dsd 201 aer properly prior to the start of a cycle subsequently causing the reported event to occur.The reservoirs inside the unit's cabinet that houses the chemistry for each side of the unit have a heater on them that should be set between 38-40c.The user facility had their reservoirs set at 34c.There are temperature sensors on both sides of the unit that were set at 30c, but should have been set to 36c.The technician also observed that the temperature sensors were disabled.The user facility's biomedical technician had disabled the sensors due to a reoccurring alarm.The reoccurring alarm was due to the temperature sensors not being within the required settings.The technician was able to review cycle printouts which confirmed that the temperatures were too low to meet the minimum temperature requirements on the rapicide glutaraldehyde labeling.The dsd 201 aer is manually programed so if the user does not set up the programming correctly and ineffective cycle will occur.During the in-service training it was also observed that user facility personnel were using modified hook-ups.User facility personnel were modifying the hook-ups by utilizing olympus cleaning adaptor tubing and putting medivators basin connectors on the end of it.Prior to reprocessing, users must verify that the hookup used contains connections for all appropriate channels that require a separate reprocessing connection according to the hookup instructions.Medivators makes no claim on high-level disinfection efficacy when these reprocessing instructions are not followed, or when this hookup kits are used other than those specified in the hookup guide.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 endoscope reprocessing system cannot be guaranteed unless devices are processed in accordance with medivators instructions for processing and use.Steris technician completed his in-service training on the proper use and operation of the dsd 201 aer and returned the unit to service.No additional issues have been reported.

Event Description

A steris infection prevention tech was performing in-service training on the dsd 201 aer and was informed by user facility personnel that their cycle temperatures were too low and not meeting the minimum temperature requirements as stated on the rapicide glutaraldehyde labeling.The scopes processed in the dsd 201 aer were subsequently used during patient procedures.No report of injury.

• Brand Name: DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSING SYSTEM
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 16383716
• MDR Text Key: 309761345
• Report Number: 2150060-2023-00010
• 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: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• 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: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2011
• 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