• 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 OMNI-TOME 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 OMNI-TOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Catalog Number FS-OMNI
Device Problem Material Separation (1562)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved determined the cutting wire securing component located near the distal end of the sphincterotome has disconnected from the catheter. The condition of the device prohibited a functional test because the cutting wire securing component located near the distal end of the sphincterotome has disconnected from the catheter. The cutting wire is intact and remains securely attached to the sphincterotome at the proximal end. However, due to the catheter and securing component disconnection, the distal end of the cutting wire is no longer connected to the sphincterotome catheter. A section of the cutting wire securing component has broken and detached from the device. The broken section is estimated to be 3 mm in length and 0. 5 mm in diameter. The broken section was not included in the return. The cutting wire does not show evidence of cautery application. A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed. 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. Separation of the cutting wire securing component and the catheter can occur if the tip of the sphincterotome is over flexed. The instructions for use caution the user: "do not over flex or bow tip beyond 90 degrees, as this may damage or cause cutting wire to break. " this type of damage 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 separation of the cutting wire securing component and the catheter 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. 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. " prior to distribution, all fusion omni-tome sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity. The functional test includes bowing the sphincterotome to ensure the distal end responds to handle manipulation. 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
In preparation for a procedure, the user selected a cook fusion omni-tome sphincterotome. The cutting wire of the sphincterotome was broken during pre-test. There was no reportable information at this time. The device was evaluated on (b)(6) 2018 and the investigation determined that the cutting wire securing component had separated, and 3 mm detached and was not included in the return. This occurred prior to patient contact; there was no impact to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFUSION OMNI-TOME
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 Key7855788
MDR Text Key119663202
Report Number1037905-2018-00396
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 07/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/09/2020
Device Catalogue NumberFS-OMNI
Device Lot NumberW3835703
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-