MAUDE Adverse Event Report: COVIDIEN LP SHARKCORE; BIOPSY NEEDLE

Model Number	DSC-22-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Dr made one pass with fnb needle without problem.During the second pass, the needle would not advance.Staff removed the needle from the scope and the needle advanced.Needle was reinserted and the needle would not advance when in the scope.A new needle was opened and was used without problem and no harm came to the patient.The rep was notified by staff.Manufacturer response for biopsy needle, sharkcore (per site reporter).Device will be returned for failure analysis.Awaiting reply from manufacturer.

• Brand Name: SHARKCORE
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 9693749
• Report Number: 9693749
• Device Sequence Number: 2844554
• Product Code: FCG
• UDI-Device Identifier: 00855208005087
• UDI-Public: (01)00855208005087
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2019
• Report Date (Section F): 12/11/2019

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 Model Number: DSC-22-01
• Device Catalogue Number: DSC-22-01
• Device Lot Number: B000000881
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 43
• Date Report Sent to FDA: 12/11/2019