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

Model Number G31521

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.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 was confirmed based off the pictures the customer provided.Two (2) pictures were taken, one of the outside of the pouch and one of the needle inside the plastic tray.In the picture, the needle was sticking out from the distal end of the sheath.There was a bend in the sheath distal to the handle.The lot number could not be confirmed from the picture due to it being grainy when zooming in.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: 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 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." "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 ultrasound procedure (eus), the physician used a cook echotip ultra endoscopic ultrasound needle.The user advanced the device to the desired position and pulled out part of the inner wire.The user found out the needle cannot be retracted into sheath after first attempt of biopsy.The user changed to another of the same device to complete 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: 8866789
• MDR Text Key: 153525357
• Report Number: 1037905-2019-00450
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002315211
• UDI-Public: (01)00827002315211(17)220226(10)W4184836
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K171596
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2022
• Device Model Number: G31521
• Device Catalogue Number: ECHO-3-22
• Device Lot Number: W4184836
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• 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: 63 YR
• Patient Weight: 56