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

Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8321398
• Report Number: 2150060-2019-00013
• Device Sequence Number: 19211566
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K914145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

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
• Operator of Device: Other
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other