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

Model Number 205664

Device Problem Break (1069)

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

Event Date 02/02/1918

Event Type  Injury  

Event 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
• Type of Device: TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS
• Manufacturer (Section D): BOSTON SCIENTIFIC/ENDOCHOICE; alpharetta GA 30009
• MDR Report Key: 7276130
• MDR Text Key: 100439274
• Report Number: MW5075302
• 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: 205664
• Device Catalogue Number: CEK72120
• Device Lot Number: 2056646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• 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 Weight: 45