MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. ECHOTIP ULTRA FIDUCIAL NEEDLE; NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT

Catalog Number ECHO-22-F

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

During an endoscopy procedure, the physician used a cook echotip ultra fiducial needle.The needle would not move when the handle was manipulated [needle was not able to be retracted].When they took the needle outside the endoscope and moved the handle back-and-forth the needle moved fine.Then they put a bend to simulate an elevator with their fingers, then the handle would float with out moving the needle.The procedure was completed with another device of the same type.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.

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.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"."visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use"."device may not be used prior to training by mfr"."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 needle tip can slowly be retracted and advance into another site to place additional fiducials as needed".The instructions for use state, "attach device to accessory channel port".The instructions for use also cautions the user that, "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 severe bending of the needle near the distal end.This can 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, 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.

• Brand Name: ECHOTIP ULTRA FIDUCIAL NEEDLE
• Type of Device: NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, manager ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4652625
• MDR Text Key: 15915534
• Report Number: 1037905-2015-00132
• Device Sequence Number: 1
• Product Code: NEU
• 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: Health Professional,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2015
• Device Catalogue Number: ECHO-22-F
• Device Lot Number: W3458243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE (UNK MODEL NUMBER)