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

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A facility reported residue on the flexible rubber sheaths of egd endoscopes after being reprocessed in their dsd-201 automated endoscope reprocessors (aers).There is potential for patient exposure to the unknown residual if used in subsequent procedures.Medivators technical services advised the facility to try increasing their rinse time during the reprocessing cycle and to ensure proper manual cleaning processes are being followed.Medivators regulatory followed up with the facility for additional information.The facility reported they continue to see the residue on the flexible rubber sheaths of egd endoscopes.They did not report any errors or alarms generated from the aers during reprocessing.There was no information provided regarding the water quality or other products ued in their reprocessing processes.According to medivators technical and clinical specialist, the rubber sheath appeared to be in very poor condition.The discoloration does not appear to be a residue but rather the high-level disinfectant may be highlighting the poor condition of the bending rubber.The discoloration is consistent with stress and age condition of the bending rubber.It is the responsibility of the facility to ensure endoscopes are in good condition when being used and reprocessed.Damaged endoscopes could potentially cause patient harm and are not to be reprocessed in medivators aers.There have been no reports of patient harm.Medivators remains in close contact with the facility.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
A facility reported residue on the flexible rubber sheaths of egd endoscopes after being reprocessed in their dsd-201 automated endoscope reprocessors (aers).There is potential for patient exposure to the unknown residual if used in subsequent procedures.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8034920
• Report Number: 2150060-2018-00069
• Device Sequence Number: 13778820
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/02/2018

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: Other
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 11/02/2018
• 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