• 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 FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE 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 FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Catalog Number FS-OMNI-ACRO-35-450
Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Align (2522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2017
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 evaluation of the photos provided from the customer show incorrect orientation of the sphincterotome in the endoscopic view and confirmed the complaint of incorrect orientation. However, without return of the complaint device, further investigation cannot be completed. 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. Improper cutting wire orientation can occur if the distal end of the catheter is shaped manually. This sphincterotome catheter is precurved and is provided with a precurved stylet in the distal tip of the catheter. This obviates the need for manual formation. The instructions for use contain the following comment: ¿note: do not apply manual pressure to tip or cutting wire of sphincterotome in an attempt to influence orientation, as this may result in damage to device. ¿ other factors that can contribute to improper cutting wire orientation include manipulating the handle with the catheter in a coiled position or with the precurved stylet inside the cannulating tip. The instructions for use advise the user: "upon removing device from package, uncoil and straighten sphincterotome. "the user is then instructed to "carefully remove precurved stylet from cannulating tip. " the instructions for use contain the following comment: "note: do not exercise handle while device is coiled or precurved stylet is in place, as this may cause damage to sphincterotome and render it inoperable. " information was provided that prior to use poor orientation was observed at the tip. The instructions for use advise the user: "if package is opened or damaged when received, do not use. Visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use. " prior to distribution, all fusion pre-loaded with acrobat wire guide sphincterotomes 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: 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. Additional comments regarding this report: based on the information provided that poor orientation was observed prior to use and the device was used, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
 
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion with preloaded acrobat wire guide. When they opened the package and removed the stylet, poor orientation at the tip of the sphincterotome was seen. They tested it [the device] and saw in the papilla the bad orientation [the cutting wire oriented incorrectly to the papilla].
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE
Type of DeviceKNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
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 Key6322494
MDR Text Key67329088
Report Number1037905-2017-00048
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K052051
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 01/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFS-OMNI-ACRO-35-450
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/16/2017
Device Age1 MO
Event Location Hospital
Date Manufacturer Received01/16/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/14/2016
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: 02/10/2017 Patient Sequence Number: 1
Treatment
PENTAX DUODENOSCOPE, UNKNOWN MODEL
-
-