MAUDE Adverse Event Report: MEDIVATORS SCOPE BUDDY; ENDOSCOPE FLUSHING AID

Model Number EFA-US-G

Device Problem Device Reprocessing Problem (1091)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

The operator of the scope buddy noticed the unit had come unplugged post procedure.The scope was not flushed prior to being put in the dsd-201 aer.This is not a serious injury, but could potentially lead to patient harm.To date, there have been no reports of patient illness or injury.Medivators field staff are in contact with this facility.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

The facility reported the endoscope was not properly manually cleaned prior to use in patient procedure.

• Brand Name: SCOPE BUDDY
• Type of Device: ENDOSCOPE FLUSHING AID
• 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: 6353538
• MDR Text Key: 68156486
• Report Number: 2150060-2017-00010
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2017

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: EFA-US-G
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1