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U.S. Department of Health and Human Services

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

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COVIDIEN LLC SHARKCORE LG FINE NEEDLE BIOPSY SYSTEM BIOPSY NEEDLE Back to Search Results
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).
 
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Brand NameSHARKCORE LG FINE NEEDLE BIOPSY SYSTEM
Type of DeviceBIOPSY NEEDLE
Manufacturer (Section D)
COVIDIEN LLC
MDR Report Key8817523
MDR Text Key152030457
Report NumberMW5088288
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received07/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/21/2019
Device Model NumberDSL-19-01
Device Catalogue NumberDSL-19-01
Device Lot NumberB000000361
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/22/2019 Patient Sequence Number: 1
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