• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY ECHOTIP ULTRA FIDUCIAL NEEDLE NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK ENDOSCOPY ECHOTIP ULTRA FIDUCIAL NEEDLE NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT Back to Search Results
Model Number G03793
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/27/2018
Event Type  malfunction  
Manufacturer Narrative
Information regarding 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. The instruction for use (ifu) includes the following to ensure proper use of the device: "needle must be retracted into sheath and thumbscrew on safety ring must be locked to hold needle in place prior to introduction, advancement or withdrawal of device. Failure to retract needle may result in damage to endoscope. " "stylet must not be retracted at any point. " "identify desired site based on previous findings from endoscopy, radiography, and/or ct scans. Slowly introduce needle into accessory channel of endoscope and advance in short increments. Ensure needle is completely retracted and locked in place. Note: bends or kinks in needle caused by improper introduction may result in the inability to deploy fiducials. " it is possible that the user was unable to deploy the fiducials due to a bend at the distal end of the needle. Failure to attach device to the endoscope channel can contribute to deployment difficulty. The ifu states, "attach device to endoscope accessory channel port. " 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 contributes to advancement and/or retraction difficulties. Kinks in the needle can occur if the device experiences excessive pressure during product handling/preparation. Prior to distribution, all echotip ultra fiducial needles are subjected to a visual inspection 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: 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 fiducial needle (echo-22-f). The physician was unable to expel fiducial from needle tip into the lesion. The needle was removed and inspected by the staff. The needle was bent and the fiducials inside [the needle] were stuck. The procedure was successfully completed with another echo-22-f. The additional information provided indicated that needle was bent at the distal tip. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameECHOTIP ULTRA FIDUCIAL NEEDLE
Type of DeviceNEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, 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 Key7713436
MDR Text Key114814161
Report Number1037905-2018-00321
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
PMA/PMN Number
K141356
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2018
Device Model NumberG03793
Device Catalogue NumberECHO-22-F
Device Lot NumberW3909246
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/24/2018 Patient Sequence Number: 1
Treatment
OLYMPUS ENDOSCOPE, UNKNOWN MODEL
-
-