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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/15/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Medivators clinical specialist observed the facility had pieced together scope buddy tubing instead of using the correct tubing with pentax cleaning adaptors for flushing endoscope channels using the scope buddy endoscope flushing aid.By not using the oem cleaning adaptors and tubing, the scope channels may not be flushed with enough detergent fluid volumes to meet endoscope manufacturer's requirements.After being flushed by scope buddy, a subsequent high-level disinfection is performed on endoscopes.Since the observation, the facility has purchased the correct cleaning adaptor.It is unknown how many endoscopes were flushed using the incorrect tubing.To date, there have been no reports of patient illness or injury.This complaint will continue to be monitored within the medivators complaint handling system.

Event Description

Medivators clinical specialist observed the facility had pieced together scope buddy tubing instead of using the correct tubing with pentax cleaning adaptors for flushing endoscope channels using the scope buddy endoscope flushing aid.By not using the oem cleaning adaptors and tubing, the scope channels may not be flushed with enough detergent fluid volumes to meet endoscope manufacturer's requirements.

• 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: kristin bergeson ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 5291292
• MDR Text Key: 33342012
• Report Number: 2150060-2015-00040
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2013
• 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