• 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 HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES

  • 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 HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES Back to Search Results
Catalog Number HPC-3
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/31/2019
Event Type  Injury  
Manufacturer Narrative
Information regarding section reporter occupation: non-healthcare professional. Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report. During our laboratory analysis, the needle knife was advanced through a duodenoscope that was placed in a simulated biliary position. While in an open position, the needle was retracted approximately 10 mm into the catheter of the device. The handle of the device was then manipulated however no part of the needle protruded from the scope. During manipulation of the handle, the tip of the needle was located underneath the black distal tip of the catheter, so no measurement of the needle location could be taken. The detached portion of the needle was also returned. The segment of the needle was bent and measured between 6 mm and 7 mm in length. According to the product drawing, the needle is specified to extend 4mm +/- 2mm from the catheter. A visual inspection of the needle portion that returned exhibits evidence of a cautery application (blackening of the needle was noted) and a rounded edge. An unknown liquid within the tubing was also noted during the visual examination. It is unknown how the portion of the needle detached from the device. 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. Needle knife breakage near the distal end can occur if the device is used with excessive cautery settings or if the needle makes contact with the distal end of the endoscope during a cautery application. The instructions for use direct the user: "before using this device, follow recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode. Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure. " the instructions for use caution the user: "when applying current, ensure needle knife is completely out of endoscope. Contact of needle knife with endoscope may cause grounding, which can result in patient injury, operator injury, a broken needle knife, and/or damage to endoscope. " needle knife breakage near the distal end can also occur if the product experiences limited movement of the needle knife during electrocautery application. The instructions for use state: "caution: it is essential to move needle knife while applying current. " maintaining the needle knife in one position can result in breakage of the needle knife. Prior to distribution, all huibregtse triple lumen needle knives are subjected to a visual inspection and functional test 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 endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook huibregtse triple lumen needle knife. When the physician went to advance the needle knife, the tip of the needle knife came off. They were at the papilla and were advancing the needle to make contact with the patient¿s tissue but the needle knife had not penetrated the patients tissue. The needle knife came apart from the catheter inside the patient. Forceps were used to remove the broken fragment from the patient. The procedure was completed with another device of the same type. The medwatch (mw5093151) form received on 09-mar-2020 stated ¿physician was using hpc-3 huibregtse triple lumen needle knife during a procedure. The needle knife dropped off and fell into the pt. Physician visualized it and was able to remove it using forceps through the edg scope. No pt injury or extra procedure or recovery time needed. Fda safety report id# (b)(4). ¿ the detached portion did not remain inside the patient¿s body. The patient required removal of the broken tip with the use of forceps 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 NameHUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE
Type of DeviceKNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES
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 Key9832217
MDR Text Key189744808
Report Number1037905-2020-00134
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972674
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 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/18/2022
Device Catalogue NumberHPC-3
Device Lot NumberW4205339
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2019
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: 03/13/2020 Patient Sequence Number: 1
-
-