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

Device Problems Facilities Issue (2935); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported a white residue on their endoscopes after reprocessing in their dsd-201 automated endoscope reprocessor (aer).Testing performed by the facility indicated the residue was a byproduct of the non-medivators filters the facility was using in their aer.There is potential for patient harm caused by exposure to the residue during endoscopic procedures.It is unknown which filters the facility was using in their aer.Medivators technical service recommended the facility purchase and use filters through medivators.It is unknown if the endoscopes with the reported residue were used during patient procedures.There have been no reports of patient harm.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

The facility reported a white residue on their endoscopes after reprocessing in their dsd-201 automated endoscope reprocessor (aer).Testing indicated the residue was a byproduct of the non-medivators filters the facility was using in their aer.There is potential for patient harm caused by exposure to the residue during endoscopic procedures.

• Brand Name: DSD-201
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: sadie martin ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 7325263
• MDR Text Key: 101955851
• Report Number: 2150060-2018-00018
• Device Sequence Number: 1
• Product Code: FEB
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/08/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2006
• 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