MAUDE Adverse Event Report: COVIDIEN, LLC. 25G SHARKCORE NEEDLE; BIOPSY NEEDLE

Lot Number B000001519

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

Presented to endoscopy (b)(6) 2021 for upper endoscopic us with fnb performed.Reported during the fna procedure, the needle used was able to be successfully passed the first time but when provider went to do the second pass, the needle did not come out of the sheath.Provider attempted to trouble shoot and could not get it to operate.The staff opened a second needle and that needle remained operational with the procedure completed successfully.Fda safety report id # (b)(4).

• Brand Name: 25G SHARKCORE NEEDLE
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): COVIDIEN, LLC.
• MDR Report Key: 12225610
• MDR Text Key: 263567910
• Report Number: MW5102754
• Device Sequence Number: 1
• Product Code: FCG
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: B000001519
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Age: 57 YR