MAUDE Adverse Event Report: MEDIVATORS INC. SSD-102; AUTOMATED ENDOSCOPE REPROCESSOR

Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medivators clinical education specialist was at the facility performing an in service when he noticed the facility was using rapicide glutaraldehyde high level disinfectant with their ssd-102 automated endoscope reprocessor.The facility usually reprocesses endoscopes using rapicide opa high level disinfectant.Rapicide glutaraldehyde and rapicide opa require different test strips and settings.The facility continued to use rapicide opa test strips and settings while reprocessing with rapicide glutaraldehyde hld for a day and a half.In accordance with the ssd-102 aer instructions for use, the efficacy of the disinfectant must be monitored daily using the correct test strips.If the potency is below the minimum recommended concentration, the chemistry should be discarded and replaced with fresh solution.Using the incorrect test strips would not have indicated the correct mrc per the chemistry used.Additionally, the ifu states the user should verify the settings are appropriate for the disinfectant used.Thus, the facility was not reprocessing endoscopes in accordance with the aer's ifu and there is potential high level disinfection of the endoscopes was not reached.Medivators clinical education specialist informed the facility that the chemistry used was incorrect while using the rapicide opa test strips and settings.The facility will begin to order rapicide opa hld again.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
Medivators clinical education specialist was at the facility performing an in service when he noticed the facility was using rapicide glutaraldehyde high level disinfectant with their ssd-102 automated endoscope reprocessor.The facility usually reprocesses endoscopes using rapicide opa high level disinfectant.Rapicide glutaraldehyde and rapicide opa require different test strips and aer settings.The facility continued to use rapicide opa test strips and settings with rapicide glutaraldehyde hld.The facility was not reprocessing endoscopes in accordance with the aer's ifu and there is potential high level disinfection of the endoscopes was not reached.

• Brand Name: SSD-102
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7119147
• Report Number: 2150060-2017-00053
• Device Sequence Number: 11007458
• Product Code: FEB
• UDI-Device Identifier: 00677964035647
• UDI-Public: 00677964035647
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

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: 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: 11/20/2017
• Initial Report FDA Received Date: 12/14/2017
• 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