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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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COOK ENDOSCOPY FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Catalog Number FS-OMNI-35-260
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2016
Event Type  Malfunction  
Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved determined that 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 at the distal end. No section of the sphincterotome device is missing. 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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation. A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product. 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 pre-curved and is provided with a pre-curved 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. ¿ if the elevator of the endoscope remains in the closed/up position when retraction of the sphincterotome is attempted and additional pressure is applied, this could have contributed to separation of the catheter and cutting wire securing component. The instructions for use caution the user the "elevator should remain open/down when advancing or retracting sphincterotome. " this activity will aid in device preservation. 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 to "uncoil and straighten sphincterotome" upon removing the device from the packaging. 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. " prior to distribution, all fusion omni-tome pre-loaded 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: 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 cholangiopancreatography (ercp), the physician used a cook fusion omni-tome pre-loaded sphincterotome. The cutting wire got loose from the tip. It was broken in the distal part of the device [cutting wire breaks at proximal end]. The device was received for evaluation on 12/05/2016. It was found during the investigation that the cutting wire securing component had separated from the catheter.

 
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Brand NameFUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
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 Key6214002
MDR Text Key63625705
Report Number1037905-2016-00515
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeES
PMA/PMN NumberK052051
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 12/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberFS-OMNI-35-260
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/15/2016
Device Age3 mo
Event Location Hospital
Date Manufacturer Received12/05/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/14/2016
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: 12/29/2016 Patient Sequence Number: 1
Treatment
OLYMPUS ENDOSCOPE, UNKNOWN MODEL
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