MAUDE Adverse Event Report: PHILIPS MOBILE PHILIPS BY ENDURA; MOBILE FLUOROSCOPY C-ARM

Model Number BV ENDURA

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/29/2016

Event Type  Injury  

Event Description

During an elective ercp (for removal of a gallstone in common bile duct) at the process of capturing and crushing the stone (which is performed entire) under radiologic visualization), the fluoroscopy machine's handswitch failed to work.An intermittent failure of the hand-switch o this unit was identified and the pt needed to stay in hospital for an add'l day to repeat procedure the next day on another unit.(b)(4).

• Brand Name: MOBILE PHILIPS BY ENDURA
• Type of Device: MOBILE FLUOROSCOPY C-ARM
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 6204784
• MDR Text Key: 63403397
• Report Number: MW5066907
• Device Sequence Number: 1
• Product Code: JAA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BV ENDURA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR