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

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/14/2019

Event Type  Injury  

Manufacturer Narrative

During a service visit, a medivators field service engineer (fse) reported a facility had not been performing water line disinfection (wld) cycles for their four dsd edge automated endoscope reprocessors (aer).There is potential risk of contamination of the endoscopes reprocessed in the aers from not performing wld in accordance with the aer user manual.Medivators fse discovered the facility had not performed wld since the four aers were installed on (b)(6) 2018.The number of endoscopes reprocessed during this time is unknown.Medivators fse retrained the facility on the importance of completing a wld as instructed in the aer user manual.There have been no reports of patient adverse events.This complaint will continue to be monitored in medivators complaint handling system.

Event Description

During a service visit, a medivators field service engineer (fse) reported a facility had not been performing water line disinfection (wld) cycles for their four dsd edge automated endoscope reprocessors (aer).There is potential risk of contamination of the endoscopes reprocessed in the aers from not performing wld in accordance with the aer user manual.

• Brand Name: DSD EDGE
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: hannah shrader ; 14605 28th ave n; minneapolis, MN 55447 ; 7635596863
• MDR Report Key: 8471059
• MDR Text Key: 140540676
• Report Number: 2150060-2019-00026
• 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: K092387
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2018
• 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