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

Model Number DSD-201

Device Problem Device Reprocessing Problem (1091)

Patient Problem Chemical Exposure (2570)

Event Date 05/07/2015

Event Type  No Answer Provided  

Event Description

Facility requested medivators service their dsd-201 automated endoscope reprocessors (aers) after reports of a patient potentially having a reaction to rapicide opa/28 high-level disinfectant.Improper rinsing and residuals left on the scope could lead to potential chemical colitis.

Manufacturer Narrative

Facility requested medivators service their dsd-201 automated endoscope reprocessors (aers) after a patient possibly had a reaction to rapicide opa/28 high-level disinfectant.It was found that the external water regulator setting had been changed.On another aer, the 0.2 micron water filter was clogged and the external water regulator setting had also been changed.The settings were fixed and the water filter was replaced.All aers were serviced to perform according to specification.The medivators field service engineer reviewed with the facility how to properly maintain their aers and water filtration system.If the aers were not rinsing the endoscopes properly at the end of reprocessing cycles, it is possible for there to be residual disinfectant on the scope that could cause potential chemical colitis.It was reported that the patient is ok.To date, there have been no other complains of patient reaction to the disinfectant.This complaint will continue to be maintained in the medivators complaint handling 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: kristin bergeson ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 4816164
• MDR Text Key: 22152606
• Report Number: 2150060-2015-00016
• 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: Replace
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• 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
• Date Manufacturer Received: 05/07/2015
• 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: Unknown
• Patient Sequence Number: 1