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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 Accessory Incompatible (1004); Nonstandard Device (1420); Retraction Problem (1536); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2020
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 customer provided a picture of the proximal end of the handle. The picture was a close up of the inside of the handle, where the stylet is inserted into the device. There appeared to be a piece of debris next to the hole for the stylet. The picture is inconclusive for retraction difficulties. 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. 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 a biopsy procedure, the physician used a cook echotip ultra endoscopic ultrasound needle. The user completed the biopsy and intended to retract needle into sheath, but found the stylet cannot be retracted. There were two holes at stylet hub. 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.
 
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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 Key10350157
MDR Text Key205585645
Report Number1037905-2020-00303
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K171596
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-3-22
Device Lot NumberW4302071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2019
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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