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

Device Problems Residue After Decontamination (2325); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2018

Event Type  Injury  

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 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
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447
• MDR Report Key: 7899931
• MDR Text Key: 121438424
• Report Number: 2150060-2018-00065
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964035647
• UDI-Public: 00677964035647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other