MAUDE Adverse Event Report: OLYMPUS AMERICA, INC. / OLYMPUS CORPORATION OF THE AMERICAS INJECTORFORCE MAX; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Model Number NM-400U-0425

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2020

Event Type  malfunction  

Event Description

Olympus injectorforce max product was placed through colonoscope and the needle would not extend out of the catheter when deployed.When removed from colonoscope, an attempt was made to extend needle and it failed again.Fda safety report id# (b)(4).

• Brand Name: INJECTORFORCE MAX
• Type of Device: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): OLYMPUS AMERICA, INC. / OLYMPUS CORPORATION OF THE AMERICAS
• MDR Report Key: 10559845
• MDR Text Key: 207968450
• Report Number: MW5096762
• Device Sequence Number: 1
• Product Code: FBK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: NM-400U-0425
• Device Catalogue Number: NM-400U-0425
• Device Lot Number: 01K
• 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