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

Model Number G03793

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was visually evaluated.The device was returned with the needle retracted inside the sheath, while the handle was in a retracted position.The stylet wire had a slight bend on the proximal end.During a functional test, the handle of the device was manipulated several times and the needle did not advance.The handle provided no resistance and the needle did not seem to be moving inside the sheath or the handle.Upon further examination, the proximal end of the needle cannula has slid out from the back side of the threaded hub.The needle cannula had slid back over the stylet wire.Due to the needle cannula being broken and no longer attached to the threaded hub, handle manipulation would not advance the needle.The handle was then disassembled, and it was confirmed that the needle had separated from the threaded hub of the device.The proximal end of the needle cannula was flared, where it had been attached to the threaded hub.The flared end of the needle cannula experienced some damage during disassembly.It is unknown how the break occurred.During a visual examination of the threaded hub, adhesive was present on the threads.There was a bend on the needle, which was not visible while the needle was inside the sheath.All four fiducial markers were present and none of them were deployed.The bevel of the needle was still intact.The device history record for the lot number said to be involved was reviewed.The vendor lot and sub lot from the device history record, for the needle components were also reviewed.The incoming raw material from the vendor was reviewed for tensile strength testing of the threaded hub and needle cannula.All values were in the acceptable range.No devices that were manufactured using the supplied vendor lot remain at the distribution centers.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the joint between the needle cannula and the threaded hub failed which caused the needle cannula to detach from the threaded hub at the proximal end of the handle leading to the report of unable to advance the needle.The cause of the component failure is unknown.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: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.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 procedure, the physician used a cook echotip ultra fiducial needle.The fiducial needle was removed from the packaging per the instructions.The sheath length was adjusted.Fiducial needle was advanced down olympus gf-uct 180 endoscope.Needle was attached to the endoscope accessory port.Needle thumbscrew was loosened to advance needle to desired length.Thumbscrew was tightened.The physician attempted to advance needle into the target site by advancing needle handle to pre-positioned safety ring.However the needle handle advanced but not the needle.Needle appears to have disconnected from needle handle and was unable to advance the needle.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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 (Section G): 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: 9398638
• MDR Text Key: 220344967
• Report Number: 1037905-2019-00735
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00827002037939
• UDI-Public: (01)00827002037939(17)200529(10)W4220445
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K141356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Model Number: G03793
• Device Catalogue Number: ECHO-22-F
• Device Lot Number: W4220445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2019
• 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
• Patient Age: 60 YR