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

Model Number	205664
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/1918
Type of Reportable Event	Serious Injury
Event or Problem Description
Brush head broke off and was lodged in endoscope, this is the second (formerly reported to management and documented) occurrence with this product, but it had happened several times previous, but was discovered and removed from the scope before going into hdl processor.We do not have the specific pieces available, they were put into the trash.

• Brand Name: ENDOCHOICE COMPLIANCE ENDOKIT
• Common Device Name: TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS
• Manufacturer (Section D): BOSTON SCIENTIFIC/ENDOCHOICE; alpharetta GA 30009
• MDR Report Key: 7276130
• Report Number: MW5075302
• Device Sequence Number: 16400976
• 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: 205664
• Device Catalogue Number: CEK72120
• Device Lot Number: 2056646
• 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 Weight: 45