MAUDE Adverse Event Report: COOK ENDOSCOPY ECHOTIP ULTRA FIDUCIAL NEEDLE; NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT

Catalog Number ECHO-22-F

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the needle of the device extended outside of the sheath while the handle was in a retracted position.The needle was extended 8 mm out from the distal end of the sheath.The stylet wire was bent on the very proximal end near the finger ring suggesting excessive force applied to the stylet wire.All four (4) fiducial markers were present and none of them were deployed.During a functional test, the handle of the device was manipulated several times with the intentions of testing for advancement and retraction of the needle.During the functional test the needle did not advance or retract when manipulating the handle.The handle was then disassembled and it was discovered that the needle was separated from the cannula hub of the device.During a visual examination of the proximal end of the needle and the distal end of the cannulated hub it was noted that the device met specification.There were several kinks along the needle.Due to the condition of the device, we were unable to test for deployment of the fiducial markers.The bevel of the needle was still intact.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusions: a definitive cause for this observation could not be determined because the actual product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.The instructions for use states: "needle must be retracted into sheath and thumbscrew on safety ring must be locked to hold needle in place prior to introduction, advancement or withdrawal of device.Failure to retract needle may result in damage to endoscope." the instructions for use states: "slowly introduce needle into accessory channel of endoscope and advance in short increments.Ensure needle is completely retracted and locked in place.Note: bends or kinks in needle caused by improper introduction may result in the inability to deploy fiducials." the instructions for use states: "to place a fiducial, depress thumb ring while stabilizing stylet.Continue applying pressure until tactile feedback and ultrasound visualization indicates fiducial has been deployed.Fluoroscopy may also be used to aid in visualizing placement of fiducials." the instructions for use states: "attach device to accessory channel port." failure to attach device prior to needle adjustment or extension may result in damage to endoscope.Attaching the needle to the endoscope will also aid in preserving the device integrity and function.It is possible that if needle is against or inside a hard mass while the user applies force and manipulates the directional controls of the endoscope this could contribute to advancement and/or retraction difficulties.Kinks or bends in the needle can occur if the device experiences excessive pressure during product handling/preparation.Prior to distribution, all echotip ultra fiducial needles are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Event Description

During an endoscopic ultrasonography (eus) with fiducial placement, the physician used a cook echotip ultra fiducial needle.The needle broke in the endoscope channel.Per clarification received from the cook representative: the entire device was able to be removed [along] with the endoscope.

• Brand Name: ECHOTIP ULTRA FIDUCIAL NEEDLE
• Type of Device: NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 6140983
• MDR Text Key: 61316849
• Report Number: 1037905-2016-00484
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00827002037939
• UDI-Public: (01)00827002037939(17)170824(10)W3758813
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-22-F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/07/2016
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/07/2016
• Date Device Manufactured: 08/24/2016
• 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
• Treatment: OLYMPUS ENDOSCOPE (UNKNOWN MODEL)