• 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, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT 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, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Catalog Number HPC-3
Device Problem Material Fragmentation (1261)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 01/24/2020
Event Type  malfunction  
Manufacturer Narrative
Continued: section e. Initial reporter; 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. 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 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 an endoscopic retrograde cholangiography procedure (ercp) the physician used a cook huibregtse triple lumen needle knife. With difficult catheterization [cannulation], while making a papillary pre-cut using the pointed sphincterotome, the needle broke when the cut was activated. It is unknown how the procedure was completed. The complaint states that the needle broke, however, it was reported that "the patient was not injured". The location of the broken portion is unknown. It is unknown if any additional procedures were required. Because the reporter stated that there was no injury, it is reasonable to conclude there were no adverse effects to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE
Type of DeviceKNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT 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 Key9740052
MDR Text Key224634002
Report Number1037905-2020-00093
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K972674
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 01/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/10/2021
Device Catalogue NumberHPC-3
Device Lot NumberW4104029
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-