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

Model Number DSD-201

Device Problems Improper or Incorrect Procedure or Method (2017); Programming Issue (3014)

Patient Problem No Code Available (3191)

Event Date 09/29/2014

Event Type  No Answer Provided  

Event Description

The case states that this facility's medivators dsd-201 was programmed with only one rinse cycle instead of the required two rinse cycles.Many endoscopes were reporecessed at this setting before the facility realized this.Potential patient chemical colitis.

Manufacturer Narrative

The case states that this facility's medivators dsd-201 was programmed with only one rinse cycle instead of the required two rinse cycles.Many endoscopes were reprocessed at this setting before the facility realized this.Potential patient chemical colitis.The facility uses medivators rapicide glutaraldehyde to high level disinfect their endoscopes.The chemistry requires two rinses cycles.The facility dsd-201 machine was only set for one rinse cycle.It is unknown how many endoscopes were reprocessed at these settings.The case was reported by medivators capital specialist via product observation form.The machine was reprogrammed immediately upon these findings to have two rinse cycles.To date, there has been no reports of patient illness or injury as a result.This complaint will continue to be maintained within medivators complaint system.

• Brand Name: MEDIVATORS DSD-201
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 4210111
• MDR Text Key: 5147171
• Report Number: 2150060-2014-00043
• 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,Company Representative
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/29/2014

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: Other
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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