MAUDE Adverse Event Report: BOSTON SCIENTIFIC/ ENDOCHOICE ENDOCHOICE; TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS

Model Number 205644

Device Problem Break (1069)

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

Event Date 01/16/2018

Event Type  Injury  

Event Description

Endochoise compliance endokit hedgehog dual end brush ref cek-721-20 lot 205644 exp 08/2019.Brush end broke off and remained lodged in endoscope.

• Brand Name: ENDOCHOICE
• Type of Device: TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS
• Manufacturer (Section D): BOSTON SCIENTIFIC/ ENDOCHOICE; alpharetta GA 30009
• MDR Report Key: 7276141
• MDR Text Key: 100440361
• Report Number: MW5075303
• Device Sequence Number: 1
• Product Code: FCH
• UDI-Device Identifier: 00840253113337
• UDI-Public: (01)00840253113337
• Combination Product (y/n): N
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: 205644
• Device Catalogue Number: 0100840253113337
• Device Lot Number: 205644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 45