MAUDE Adverse Event Report: COVIDIEN LLC SHARKCORE LG FINE NEEDLE BIOPSY SYSTEM; BIOPSY NEEDLE

Model Number DSL-19-01

Device Problems Loose or Intermittent Connection (1371); Failure to Advance (2524); Output Problem (3005); Physical Resistance/Sticking (4012)

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

Event Date 07/03/2019

Event Type  malfunction  

Event Description

Two sharkcore fine needles malfunctioned during an endoscopic ultrasound fine needle aspiration case.The needle sheet was loose and kept getting stuck and did not advance into the biopsy system.A new biopsy system and needle were obtained and it was also defective.The physician then requested a different brand.I called the medtronic rep and was told to report to technical support.After contacting technical support, i was told that the needles were on back order and they were not sure when they were going to be replaced.Also i was told i was going to receive an email with an fdr form to submit for malfunctioning equipment.I have not received an email.Will attempt contacting manufacturing again.Fda safety report id# (b)(4).

• Brand Name: SHARKCORE LG FINE NEEDLE BIOPSY SYSTEM
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): COVIDIEN LLC
• MDR Report Key: 8817523
• MDR Text Key: 152030457
• Report Number: MW5088288
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/18/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2019
• Device Model Number: DSL-19-01
• Device Catalogue Number: DSL-19-01
• Device Lot Number: B000000361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2019
• 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): Other
• Patient Age: 76 YR
• Patient Weight: 76