MAUDE Adverse Event Report: MEDIVATORS INC. SSD-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	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A facility reported attempting to load the incorrect chemistry, rapicide pa high level disinfectant (hld), in their ssd-201 automated endoscope reprocessor (aer).Additionally, the scope technician loading the chemistry was exposed to rapicide pa hld on the right hand and left arm.Rapicide pa is not for use with the ssd-201 aer, therefore, the facility was not using their aer in accordance with the aer instructions for use.Thus, there is potential that endoscopes reprocessed in the aer were not appropriately high-level disinfected and, therefore, potential for patient cross-contamination.Rapicide pa part a and part b was reportedly being mixed by the user in the reservoir tank of the ssd-201 aer.Rapicide pa is a single shot chemistry that is dosed by the aer.The ssd-201 uses a reusable chemistry, thus, this is off-label use and user negligence of the instructions for use of both the chemistry and aer.Medivators technical services instructed the facility to remove the rapicide pa from the ssd-201.Medivators regulatory attempted to follow up with the facility for additional information with no success.The facility did not specify if any endoscopes were reprocessed using the incorrect hld.It is unknown if any medical attention was sought and if there were any lasting effects of the skin exposure.Additionally, it is unknown if the employee was wearing proper ppe (i.E.Gloves) when handling the hld as instructed per the product labeling.There have been no reports of patient harm.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
A facility reported attempting to load an incorrect chemistry, rapicide pa high level disinfectant (hld), in their ssd-201 automated endoscope reprocessor (aer).Additionally, the scope technician loading the chemistry was exposed to rapicide pa hld on the right hand and left arm.Rapicide pa is not for use with the ssd-201 aer, therefore, the facility was not using their aer in accordance with the aer instructions for use.Thus, there is potential that endoscopes reprocessed in the aer were not appropriately high-level disinfected and, therefore, potential for patient cross-contamination.

• Brand Name: SSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8579728
• Report Number: 2150060-2019-00039
• Device Sequence Number: 13905652
• Product Code: FEB
• UDI-Device Identifier: 00677964035647
• UDI-Public: 00677964035647
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K914145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

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: 04/03/2019
• Initial Report FDA Received Date: 05/03/2019
• 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