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

Model Number DSD-201

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/03/2018

Event Type  Injury  

Manufacturer Narrative

A medivators field service engineer was at a facility servicing a dsd-201 automated endoscope reprocessor and reported the facility was using the incorrect 0.2 micron water filter with their unit.The water filter being used is not intended to be used with the filter housing unit it was in and was found to be unattached to the filter port.There is potential that microbial contamination was introduced to the aer, thus there is potential for patient adverse effects.It is unknown how long the facility had been using the incorrect 0.2 micron water filter with their aer.The facility confirmed they had the correct 0.45 micron pre-filter and a sediment pre-filter.They have since installed the correct 0.2 micron filter in their aer.The facility is looking into getting a service contract with medivators.There have been no reports of patient harm related to potential bacterial contamination from endoscopes reprocessed in this aer.This complaint will continue being monitored in medivators complaint handling system.Facility information: (b)(6).

Event Description

A medivators field service engineer was at a facility servicing a dsd-201 automated endoscope reprocessor and reported the facility was using the incorrect water filter with their unit.There is potential for microbial contamination to be introduced while reprocessing endoscopes, thus there is potential for patient adverse effects.

• 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: 7390564
• MDR Text Key: 104132779
• Report Number: 2150060-2018-00024
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2013
• 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