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

Device Problems Improper or Incorrect Procedure or Method (2017); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer (fse) reported while onsite at the facility for a service visit that the facility's dsd-201 automated endoscope reprocessor (aer), endoscopes and hookups were stained with a green residue.There is potential for patient harm from exposure to the green residue and potential that endoscopes were not adequately high level disinfected.Medivators fse reported that the green substance is from a combination of the detergent (orthozime) mixing with the high-level disinfectant (cidex opa) used in their aer.It was determined that the facility incorrectly programmed their aer for detergent use which caused the detergent to be mixed with the high-level disinfectant in the basin during reprocessing cycles.The facility was informed by medivators fse of the potential impact to patient safety due to the coating of the green substance in the aer and on endoscopes and the potential that endoscopes are not being adequately high level disinfected.The facility received in-service training on the dsd-201 aer in 2007 and 2014 provided by medivators clinical education specialist.The dsd-201 user manual also instructs users to verify proper programming of the aer's cycle settings.It is unknown if the facility continues to use the affected aer.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

Medivators field service engineer (fse) reported while onsite at the facility for a service visit that the facility's dsd-201 automated endoscope reprocessor (aer), endoscopes and hookups were stained with a green residue.There is potential for patient harm from exposure to the green residue and potential that endoscopes were not adequately high level disinfected.

• Brand Name: DSD-201
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 8524712
• MDR Text Key: 142336143
• Report Number: 2150060-2019-00030
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2007
• 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
• Patient Outcome(s): Other