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

Device Problem Off-Label Use (1494)

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

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer (fse) reported during a service visit for a facility's dsd-201 automated endoscope reprocessor (aer) that the facility was using maxicide plus 28 day solution, a high level disinfectant (hld).Maxicide plus is not intended for use with the aer, thus there is potential that endoscopes resprocessed in the aer were not adequately high-level disinfected and therefore, potential for patient harm.It is estimated that the facility was using the incorrect hld since november 2018.Medivators fse informed the facility to replace the maxicide plus with validated product for use with their aer and confirmed at the next visit that the aer was operating according to specification using the correct hld.Medivators fse also reported, during his service visit, that most of the facility hookups were in poor condition.Facility staff were informed and medivators fse noted the facility hookups were of good quality at the next visit.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 reported during a service visit for a facility's dsd-201 automated endoscope reprocessor (aer) that the facility was using maxicide plus 28 day solution, a high level disinfectant.Maxicide plus is not intended for use with the aer, thus there is potential that endoscopes reprocessed in the aer were not adequately high-level disinfected and, therefore, potential for patient harm.

• Brand Name: DSD-201
• 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: 8321398
• MDR Text Key: 135607259
• Report Number: 2150060-2019-00013
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• 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: 01/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other