MAUDE Adverse Event Report: MEDTRONIC BEACON EUS DELIVERY SYS SHARKCORE FNB PRELOADED 19; GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT

Model Number DSL-19-01

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported misplacing the safety sheath from the needle during removal of the needle from the system to the cytology table.Customer was using dsl-19-01 and exchanged the 19 gauge needle for a 25 gauge for the case.Adequacy was achieved on the first pass.Physician then proceeded with 3 additional passes for more tissue.During the last exchange, the tech felt the needle disengage from system and safety sheath was not present covering the needle.The room and patient bed were searched for the safety sheath, the sheath was not found.The system was also inspected and the safety sheath was not present.Customer ordered a patient x-ray and sheath was not present in the patient.Sales rep explained to account the safety sheath is too large to enter the scope and entering the patient is not possible.Account also stated the scope has a blockage in the working channel.

• Brand Name: BEACON EUS DELIVERY SYS SHARKCORE FNB PRELOADED 19
• Type of Device: GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
• Manufacturer (Section D): MEDTRONIC; 540 oakmead parkway; sunnyvale CA 94085
• Manufacturer (Section G): MEDTRONIC; 540 oakmead parkway; sunnyvale CA 94085
• Manufacturer Contact: sharon murphy ; 540 oakmead parkway; sunnyvale, CA 94085 ; 2034925267
• MDR Report Key: 5866598
• MDR Text Key: 51814442
• Report Number: 3004904811-2016-00058
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSL-19-01
• Device Catalogue Number: DSL-19-01
• Device Lot Number: ML00003416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention