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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 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.
 
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Brand NameECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Type of DeviceFCG, 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 Key8028709
MDR Text Key126652519
Report Number1037905-2018-00503
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002315211
UDI-Public(01)00827002315211(17)210403(10)W4049887
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171596
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/03/2021
Device Catalogue NumberECHO-3-22
Device Lot NumberW4049887
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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