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

Model Number	205644
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS
• Manufacturer (Section D): BOSTON SCIENTIFIC/ ENDOCHOICE; alpharetta GA 30009
• MDR Report Key: 7276141
• Report Number: MW5075303
• Device Sequence Number: 10804186
• Product Code: FCH
• UDI-Device Identifier: 00840253113337
• UDI-Public: (01)00840253113337
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 45