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

Catalog Number ECHO-3-22

Device Problems Retraction Problem (1536); Material Twisted/Bent (2981); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2020

Event Type  malfunction  

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 pictures provided are inconclusive for retraction difficulties.The first picture is of the distal end of the device.There is a slight bend in the needle.The second picture is of the front of the pouch.The lot number is visible and matches the lot number in the report.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 (eus) the physician used a cook echotip ultra endoscopic ultrasound needle.The physician opened the package and completed the first biopsy, but found out the needle could not be retracted while attempting the second biopsy.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.

Event Description

During an endoscopic ultrasound (eus) the physician used a cook echotip ultra endoscopic ultrasound needle.The physician opened the package and completed the first biopsy, but found out the needle could not be retracted while attempting the second biopsy.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: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.The pictures provided are inconclusive for retraction difficulties.The first picture is of the distal end of the device.There is a slight bend in the needle.The second picture is of the front of the pouch.The lot number is visible and matches the lot number in the report.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned without the stylet and the needle extending out the distal end, however the handle was in the fully retracted position.There is a slight bend in the needle.During a function test the needle was attempted to be retracted, however this could not be done due to the handle being stiff and there was a grinding feeling coming from the handle.The proximal hub on the handle was unscrewed and it was noted that the needle was detached inside the handle.The thumb tab on the distal end was removed to further examine the distal end of the inside of the handle.The needle and sheath were kinked together and the needle had detached from the inside of the handle.No other anomalies were detected with the device.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: the root cause of being unable to advance the needle, was due to the needle breaking inside the handle.The needle broke due to kinking of the internal handle components and the needle component.The cause of the kinking is unknown.The instructions for use include the following information to ensure proper use of the device: "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." 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.

• 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
• MDR Report Key: 10036606
• MDR Text Key: 227001146
• Report Number: 1037905-2020-00200
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315218
• UDI-Public: (01)10827002315218(17)220918(10)W4262552
• Combination Product (y/n): N
• PMA/PMN Number: K171596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2022
• Device Catalogue Number: ECHO-3-22
• Device Lot Number: W4262552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS JF-260 ULTRASOUND ENDOSCOPE; ULTRASOUND ENDOSCOPE, UNKNOWN MAKE OR MODEL
• Patient Age: 70 YR
• Patient Weight: 82