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

Model Number DSD EDGE

Device Problem Insufficient Information (3190)

Patient Problem Inflammation (1932)

Event Date 05/13/2014

Event Type  No Answer Provided  

Event Description

The case states that a facility reported one confirmed case of chemical colitus two weeks after having an endoscopy procedure.

Manufacturer Narrative

Facility reported one confirmed case of chemical colitus.This was reported two weeks after the procedure was performed.The facility called (b)(6) department to ensure appropriate reprocessing procedures were being followed.The technical service representative checked their dsd edge machine and it was determined everything was operating according to specification including software validation/programming.Medivators records show that this facility purchases medivators rapicide pa chemistry to reprocess their scopes.It was not confirmed that this was the chemistry used to reprocess the scope used on the chemical colitus case.It was reported that the scope used on this patient is still in rotation to perform other procedures.There have been no additional complications or cases of chemical colitus reported since this incident.Medivators ra tried to follow up with the facility for additional details, yet the point of contact could only provide limited information.This complaint will continue to be monitored within medivators complaint system.

• 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 ; 7635533300
• MDR Report Key: 3863532
• MDR Text Key: 4456472
• Report Number: 2150060-2014-00021
• 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: User Facility
• Reporter Occupation: Hospital Service Technician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/09/2014

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 EDGE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2010
• 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
• Treatment: RAPICIDE PA