MAUDE Adverse Event Report: COOK ENDOSCOPY ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG, BIOPSY NEEDLE KIT

Catalog Number ECHO-3-22

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The stylet wire was returned with the device; however, the prepackaged syringe was not included in the return.During a functional evaluation the needle adjuster was placed on "8" and the sheath adjust was placed on "5", and the handle was manipulated.The needle would advance and retract as intended.There was a [significant] bend in the sheath of the device at 134.7 cm from the base of the handle.This bend was near the distal end of the device and indicated that the needle was bent.When the needle was advanced outside the distal end of the sheath, the needle was bent near the distal tip of the sheath.There were no additional bends or kinks throughout the length of the device.A second functional test was performed by placing the device down an olympus gf-uc160p (3.2 mm channel endoscope) ultrasound endoscope.The endoscope was placed in a curved position and the device advanced through the endoscope without resistance.The device was attached the biopsy port, per the instructions for use.When manipulating the handle of the device, the needle would advance outside the distal end of the sheath very slowly.The needle would retract without any resistance felt.The location of the bend in the device most likely contributed to the slow advancement of the needle when manipulating the handle.The bend in the device is near the endoscope's elevator when the needle is inside the sheath.When the endoscope was placed in a straight position, the needle would advance and retract as intended.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 conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use include the following information to ensure proper use of the device: "needle must be fully retracted into sheath and thumbscrew on safety ring must be locked at 0 cm mark to hold needle in place prior to introduction, advancement or withdrawal of device.Failure to retract needle may result in damage to endoscope." "attach device to accessory channel port by rotating device handle until fittings are connected." "with ultrasound endoscope and device straight, adjust needle to desired length by loosening thumbscrew on safety ring, and advancing it until desired reference mark for needle advancement appears in the window of safety ring.Tighten thumbscrew to lock safety ring in place.Note: number in safety ring window indicates extension of needle in centimeters.Caution: during needle adjustment or extension, ensure device has been attached to accessory channel.Failure to attach device prior to needle adjustment or extension may result in damage to endoscope." it is possible that if the needle is against or inside a hard mass while the user applies force and manipulates the directional controls of the endoscope, it could contribute to severe bending of the needle near the distal end.This contributes to advancement and/or retraction difficulties.Bends and kinks in the sheath can occur if the device experiences excessive pressure.Prior to distribution, all echotip ultra endoscopic ultrasound 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.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 ultrasonography (eus), the physician used a cook echotip ultra endoscopic ultrasound needle.The physician tried to put the needle down the endoscope and was having trouble pushing it through.The physician pulled the needle out and it was bent about 6 or 7 cms, distal to the tip itself.Another g31521-echo-3-22 was used to completed the procedure.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 ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG, 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: 8028709
• MDR Text Key: 126652519
• Report Number: 1037905-2018-00503
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002315211
• UDI-Public: (01)00827002315211(17)210403(10)W4049887
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2021
• Device Catalogue Number: ECHO-3-22
• Device Lot Number: W4049887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2018
• 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