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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG, BIOPSY NEEDLE KIT
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COOK ENDOSCOPY ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG, BIOPSY NEEDLE KIT Back to Search Results
Catalog Number ECHO-3-22
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2018
Event Type  malfunction  
Manufacturer Narrative
Continued from section 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 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 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.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, this could contribute to severe bending of the needle near the distal end.This could contribute to advancement and/or retraction difficulties.A kink in the needle and outer sheath can prevent movement of the needle and/or stylet.The stylet provides additional stiffness during advancement of the needle into the lesion.If the needle is removed from the endoscope to collect a sample the stylet must be reinserted prior to advancing the needle through the endoscope.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 needle cannot be retracted into the sheath during the procedure (puncture).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 ultrasonography (eus), the physician used a cook echotip ultra endoscopic ultrasound needle.The needle cannot be retracted into the sheath during the procedure (puncture).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: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.A visual inspection was performed while removing the device from the open tray.During the visual inspection, the distal end of the sheath was observed and the needle was returned fully retracted inside the sheath.The handle of the device corresponded with the needle of the device.The needle adjuster was adjusted to position "8" and the sheath adjuster was adjusted to "5".When the handle of the device was manipulated, the needle of the device advanced and retracted as intended.During the visual inspection of the device, no bends or kinks in the device was noted.During a functional test, the device was advanced down an olympus gf-uct160p ultrasonic endoscope.Once the device was advanced outside the distal end of the endoscope, the endoscope was placed in a curved position.The luer lock at the distal end of the handle was attached to the biopsy port and the needle adjuster was placed on "8 and the sheath adjuster was adjusted to "5".When the handle was manipulated the needle would advance and retract.During a visual inspection there was no observation of needle exposure when the handle of the device is in the retracted position.The device was then tested by adjusting the sheath adjuster to "2".Again, when the handle was manipulate the needle would advance and retract smoothly.There was not any needle exposure when the handle of the device was in the retracted position.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 the reported observation could not be determined because the product said to be involved functioned as intended.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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.
 
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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 Key7781250
MDR Text Key117444337
Report Number1037905-2018-00353
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002315211
UDI-Public(01)00827002315211(17)210125(10)W4021622
Combination Product (y/n)N
PMA/PMN Number
K171596
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Type of Report Initial,Followup
Report Date 07/20/2018
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 Date01/25/2021
Device Catalogue NumberECHO-3-22
Device Lot NumberW4021622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2018
Initial Date Manufacturer Received 07/20/2018
Initial Date FDA Received08/14/2018
Supplement Dates Manufacturer Received08/29/2018
Supplement Dates FDA Received09/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FUJINON 8000 ENDOSCOPE
Patient Age67 YR
Patient Weight65
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