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

Medical Device Problem Codes	Residue After Decontamination (2325); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported their ssd 102 automated endoscope reprocessor (aer) had blue droplets left in the basin after the reprocessing and air purge cycles.There is potential risk for high level disinfectant residuals left in the endoscope thus potential chemical colitis.A medivators field service engineer (fse) confirmed the ssd 201 aer was investigated and the tubing and reservoirs of the machine have been replaced.The chemistry of the machine was switched from cidex opa28 to rapicide opa28.The medivators fse stated the facility was experiencing hard water issues and recently installed a water softener.The water was tested within specification by medivators fse.The fse ran test cycles on the aer and all cycles were within specification.The facility recently confirmed the endoscopes are not leaking blue residue into the basin after they switched to rapicide opa28.This will continue to be monitored on the medivators complaint system.
Event or Problem Description
The facility reported their ssd 102 automated endoscope reprocessor (aer) had blue droplets left in the basin after the reprocessing and air purge cycles.There is potential risk for high level disinfectant residuals left in the endoscope thus potential chemical colitis.

• Brand Name: SSD-102
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• MDR Report Key: 7899931
• Report Number: 2150060-2018-00065
• Device Sequence Number: 1434496
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/21/2018
• 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