MAUDE Adverse Event Report: GYRUS ACMI, INC. SINGLE USE ASPIRATION NEEDLE; VIZISHOT 2 FLEX

Model Number NA-U403SX-4019

Device Problem Break (1069)

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

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.Per the instruction manual recommendation to ¿always have a spare instrument available in case the primary instrument malfunctions.As a preventive measure against breakage, the instruction manual warns, ¿do not use an aspiration needle that has an irregularly bent or deformed needle tube.Do not apply bending force to the handle section.Doing so may damage the instrument and/or endoscope.If using the same instrument several times during an operation, confirm there is no irregularity of the instrument before inserting it into the endoscope.¿do not try to straighten a bent or deformed needle with your hands because the needle may break.¿.

Event Description

Olympus received a medwatch report that states during an endobronchial ultrasound (ebus) procedure, what appeared to be a soft, flexible metal spring piece was found in the patient¿s bronchus.The device fragment was safely retrieved with a forceps.There was no bleeding observed.The intended procedure was completed.This was an inpatient that was already being closely monitored.There was no patient injury reported.Additionally, olympus followed up with the user facility and was informed that the needle was used in the endoscopic field of view and under an ultrasound image.The insertion portion of the needle was coiled with a diameter of less than 150 mm.There were no kinks noted and no resistance was felt on the handle during use.The entire needle was inspected prior to use and no anomalies were found.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Type of Device: VIZISHOT 2 FLEX
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8589552
• MDR Text Key: 144852467
• Report Number: 2951238-2019-00816
• Device Sequence Number: 1
• Product Code: KTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U403SX-4019
• Device Lot Number: FR837912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1