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

Device Problems Improper or Incorrect Procedure or Method (2017); Device Contamination with Chemical or Other Material (2944); Mechanics Altered (2984); Failure to Clean Adequately (4048)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer (fse) reported a facility had been using expired test strips to check the minimum required concentration of rapicide high-level disinfectant (hld) used in their dsd-201 automated endoscope reprocessor (aer).The fse also reported brown discoloration of the intercept detergent used with their aer.Additionally, the facility removed parts, disabling one side of their dsd-201 aer, and is therefore unable to perform water line disinfection (wld).There is potential for contamination or inadequate hld of the endoscopes prior to use in patient procedures.Medivators fse informed the facility that the test strips were expired and instructed the facility to order new test strips.Rapicide hld test strips instructions for use warns users not to use the test strips after the expiration date (open or unopened).After the fse noticed the discolored detergent, the fse disabled the optional wash phase of the aer and disposed of the discolored intercept detergent.It is unknown how many endoscopes were reprocessed using the discolored intercept detergent.The source of the brown discoloration was unknown.Due to low volume of endoscopes being reprocessed, the facility removed parts and disabled side a of the dsd-201 leaving only side b operational.To perform the wld, both sides of the aer must be operational.Therefore, the facility is not able to perform wld.Per the dsd-201 ifu, it is required to perform a wld after changing a water line filter and after any service is performed on the water supply system.There have been no reports of patient harm.This complaint will continue to be monitored in medivators complaint handling system.

Event Description

Medivators field service engineer (fse) reported a facility had been using expired test strips to check the minimum required concentration of rapicide high-level disinfectant (hld) used in their dsd-201 automated endoscope reprocessor (aer).The fse also reported brown discoloration of the intercept detergent used with their aer.Additionally, the facility removed parts, disabling one side of their dsd-201 aer, and is therefore unable to perform water line disinfection.There is potential for contamination or inadequate hld of the endoscopes prior to use in patient 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: hannah shrader ; 14605 28th ave n; minneapolis, MN 55447 ; 7635596863
• MDR Report Key: 8368486
• MDR Text Key: 137114235
• Report Number: 2150060-2019-00019
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2006
• 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