SHARKCORE DSC-22-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for SHARKCORE DSC-22-01 manufactured by Covidien Lp.

Event Text Entries

[178574988] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9693749
• MDR Report Key: 9693749
• Date Received: 2020-02-11
• Date of Report: 2019-12-10
• Date of Event: 2019-11-12
• Report Date: 2019-12-11
• Date Reported to FDA: 2019-12-11
• Date Reported to Mfgr: 2020-02-11
• Date Added to Maude: 2020-02-11
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SHARKCORE
• Generic Name: BIOPSY NEEDLE
• Product Code: FCG
• Date Received: 2020-02-11
• Model Number: DSC-22-01
• Catalog Number: DSC-22-01
• Lot Number: B000000881
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 0 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN LP
• Manufacturer Address: 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-11