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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
Device Problem Failure to Align (2522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2016
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: cook fusion wire guide locking device (fs-wl-o-s). Investigation evaluation: our evaluation of the returned device confirmed the report of incorrect cutting wire orientation. During our laboratory analysis, the sphincterotome was advanced through a duodenoscope that is placed in a simulated biliary position. The duodenoscope has an accessory channel that is 4. 2 mm in diameter (model number olympus tjf-160v). The catheter exited the endoscope with the cutting wire facing 7 o¿clock. The device was then bowed and the cutting wire was facing 9 o'clock (appropriate orientation is approximately 11:00 - 1:00 o'clock). Prior to functional testing, the sphincterotome catheter was subjected to a close visual examination at the distal end as it laid flat, and twisting of the tubing was not observed. A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product. 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. Improper cutting wire orientation 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: ¿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 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: "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. 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

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome pre-loaded sphincterotome. It was reported to customer relations that, "we had problems getting the sphincterotome through the wire lock and when we did, the sphincterotome exited the endoscope with poor orientation [incorrect cutting wire orientation]. ".

 
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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 Key6202463
MDR Text Key63222702
Report Number1037905-2016-00508
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeUK
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 12/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberFS-OMNI-35
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/01/2016
Device Age4 mo
Event Location Hospital
Date Manufacturer Received12/01/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/29/2016
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: 12/23/2016 Patient Sequence Number: 1
Treatment
OLYMPUS V ENDOSCOPE
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