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

Device Problems Failure to Disinfect (1175); Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

Patient Problems Exposure to Body Fluids (1745); No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer (fse) reported that while on site at the facility, it was identified they were not following appropriate endoscope manual cleaning and reprocessing processes which could potentially result in endoscopes used in patient procedures not being adequately high-level disinfected.The fse was onsite for a preventative maintenance service on their dsd-201 automated endoscope reprocessor (aer).The aer was verified to be operating according to specification.However, the fse reported that the facility was not using the channel separators when reprocessing endoscopes in their aer.The fse informed them that they should be using the channel separators when reprocessing in their aer, as required per the instructions for use.The facility reported to the fse that their scope buddy endoscope flushing aid was plugging.When observing their processes, the fse identified that the facility was not using the scope buddy as it was intended to be used, causing the plugging.Instead of flushing the endoscopes with water, the facility is attaching the water input to the endoscope and suctioning.The fse informed them of the appropriate use of the scope buddy in accordance with the instructions for use.There have been no reports of patient adverse events as a result of the facility's endoscope manual cleaning and reprocessing processes.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

Medivators field service engineer (fse) reported that while on site at the facility, it was identified they were not following appropriate endoscope manual cleaning and reprocessing processes which could potentially result in endoscopes used in patient procedures not being 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: sadie martin ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 8186430
• MDR Text Key: 131136222
• Report Number: 2150060-2018-00077
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/20/2018

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: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2004
• 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