MAUDE Adverse Event Report: MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problems Component Incompatible (1108); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

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

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported they did not perform a waterline disinfection of their dsd edge automated endoscopes reprocessor after replacing a filter inside the machine.Endoscopes were reprocessed and used on patients before the facility performed a waterline disinfection the following day.There is potential these scopes were exposed to environmental contamination from not performing the waterline disinfection after replacing the filter and subsequently introduced to patients during procedures.Medivators field service engineer visited the facility to replace the filters and run a waterline disinfection after the facility reported concerns of not following the proper maintenance procedure.While the fse replaced the filters, he saw that when the facility personnel had replaced one of the filters, they broke one of the filter housing fittings and had replaced it with a non-medivators fitting.The fse informed the facility that non-medivators parts have not been validated for use with the machine and thus should not be used in the aer.He also went over the proper maintenance procedure for properly replacing filters and performing the waterline disinfection as requested by the facility.Medivators regulatory affairs followed up with the facility's director of patient safety & risk and she estimated that 3-5 endoscopes had been reprocessed and used on patients after the facility replaced the filter and did not run the waterline disinfection.To date, there have been no reports of patient harm caused by potential exposure to bacterial contamination.Medivators remains in contact with the facility and this complaint will continue being monitored in medivators complaint handling system.

Event Description

The facility reported they did not perform a waterline disinfect for their dsd edge automated endoscopes reprocessor after replacing a filter inside the machine.Endoscopes were reprocessed and used on patients the following day.There is potential these scopes were exposed to contamination from not performing the waterline disinfect after replacing the filter and introduced to patients during procedures.

• Brand Name: DSD EDGE
• 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: 7325478
• MDR Text Key: 101954115
• Report Number: 2150060-2018-00016
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2018

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: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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