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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 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.
 
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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 Key10036606
MDR Text Key227001146
Report Number1037905-2020-00200
Device Sequence Number1
Product Code FCG
UDI-Device Identifier10827002315218
UDI-Public(01)10827002315218(17)220918(10)W4262552
Combination Product (y/n)N
PMA/PMN Number
K171596
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/18/2022
Device Catalogue NumberECHO-3-22
Device Lot NumberW4262552
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2019
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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