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

Model Number 78400-409

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); Reaction (2414)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that a physician while performing colonoscopy procedures was experiencing anaphylactic shock symptoms.The cause for the anaphylactic reaction is unknown.It was reported that the physician has experienced this reaction multiple times.The details of the symptoms and the extent of the severity of each instance were not disclosed.Medivators field staff confirmed the physician sought additional medical attention but is back at work.Medivators field staff is still in close communication with this facility.In follow up, it was determined that the facility at which the endoscopy procedures are being performed have 2 dsd edge aers that utilize rapicide pa.It was reported that the facility is using the device as intended with the appropriate chemistry and there are no records of it operating out of specification.The facility suspected the cause for the reaction might be cidex opa, but there is limited information as to where they use this product during their scope and reusable accessories reprocessing cycle.It important to note that the reporting facility's last training in-service provided by medivators in july 2014.The facility has requested a follow-up in-service since the last anaphylactic incident.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

It was reported that a physician, while performing colonoscopy procedures, was experiencing anaphylactic shock symptoms.The cause for the anaphylactic reaction is unknown.

• 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: sadie martin ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 6501520
• MDR Text Key: 73093787
• Report Number: 2150060-2017-00019
• 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: Medical Equipment Company Technician/Representative
• Remedial Action: Notification
• Type of Report: Initial

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: No Information
• Device Model Number: 78400-409
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/18/2017
• 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
• Treatment: CIDEX OPA; MEDICLEAN EZ; RAPICIDE PA HIGH LEVEL DISNIFECTANT
• Patient Outcome(s): Other