MAUDE Adverse Event Report: MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number DSD-EDGE

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 03/24/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The case states that the rapicide pa part b high level disinfectant (hld) dosing chamber hoses were crossed on a medivators dsd edge automated endoscope reprocessor.Medivators field service engineers were on site the next day to repair the machine and it performs according to specification.The scopes reprocessed in this machine were appropriately disinfected as the part a component was dosed according to specification.Rapicide pa part a is the component in the hld that contains the active ingredients.There is potential chemical exposure to the rapicide pa part b component if scope was left sitting in the opposing basin.To date, there have been no reports of chemical exposure to the handler or patient.This complaint will continue to be monitored within medivators complaint system.

Event Description

The case states that the rapicide pa part b dosing chamber hoses were crossed on a medivators dsd edge automated endoscope reprocessor.There is potential chemical exposure to the rapicide pa part b component.

• Brand Name: DSD EDGE
• 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: 5595209
• MDR Text Key: 43271958
• Report Number: 2150060-2016-00015
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DSD-EDGE
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2016
• 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