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

Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A medivators field service engineer was dispatched for preventative maintenance (pm) servicing on a facility's dsd-201 automated endoscope reprocessor.While the fse was at the facility, he discovered that all three of their machines had major leaks along with cracked basins.The fse informed the facility that they should not be using these machines with damaged basins as any irregularities, cracks, or uneven surfaces could harbor bacteria/organisms which then could be introduced to the endoscope.There is potential for patient harm.This facility does not have a service contract with medivators so it is unknown how long these units have been damaged and how they became damaged as their units were not being serviced or repaired by medivators.It is also unknown if the facility is still using these units.It was reported that there was poor maintenance and very low overall hygiene of the facility.There has been no reported patient harm.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
A facility requested decontamination and preventative maintenance (pm) services for their dsd-201 automated endoscope reprocessor.A medivators field service engineer discovered that all three of the facility's machines had major leaks along with cracked basins.Aers with damaged basins present a risk of bacteria and organisms and could potentially lead to patient harm.It was reported that the machines were in bad condition and were not appropriately maintained.It was recommended by medivators these machines be taken out of service.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7053675
• Report Number: 2150060-2017-00050
• Device Sequence Number: 13470043
• 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: Medical Equipment Company Technician/Representative
• Remedial Action: Notification,Inspection
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/22/2017
• 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