MAUDE Adverse Event Report: HALYARD HEALTH, INC. HALYARD; ENDOSCOPIC CYTOLOGY BRUSH

Model Number 60210

Device Problems Break (1069); Detachment Of Device Component (1104); Decrease in Suction (1146); Component Missing (2306)

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

Event Date 03/31/2015

Event Type  No Answer Provided  

Event Description

Endoscopy rn reported to manager that she had retrieved a piece of a cleaning brush with the brush and tip intact from the suction channel of a pediatric colonoscope.Upon investigation, it was discovered that an issue had occurred with this scope 3 weeks prior.The licensed practical nurse (lpn) that had cleaned the scope noticed that the cleaning brush she was using to clean this scope was missing the brush end when she was done cleaning the scope.She could not be certain if the end was there prior to cleaning the scope.She put another cleaning brush down the channel and cleaned the scope without finding the missing piece of cleaning brush.The scope was leak tested and put through the reprocessing cycle without incident.The only issue noticed was a decrease in suction quality.The lpn stated that the end of the brush broke off at the brush end and she could see it in the suction port so she removed it before continuing to clean the scope.There were 2 patients who had the same colonscope used during their procedures.

• Brand Name: HALYARD
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 4780525
• MDR Text Key: 5814184
• Report Number: 4780525
• Device Sequence Number: 1
• Product Code: FDX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Nurse
• Device Model Number: 60210
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2015
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NO. NOTE: EVENT ACTUALLY OCCURRED AT (B)(6)
• Patient Age: 72 YR