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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)

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COOK ENDOSCOPY FUSION OMNI-TOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Catalog Number FS-OMNI
Device Problem Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the products 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.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: ¿note: do not apply manual pressure to tip or cutting wire of the sphincterotome 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 the sphincterotome upon removing the device from the packaging.The user is then instructed to carefully remove the precurved stylet from the 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.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) procedures, the physician used three (3) cook fusion omni-tomes.During the procedures, the knife [cutting wire] of the sphincterotomes were in the wrong position [incorrect cutting wire orientation].
 
Manufacturer Narrative
Investigation evaluation: two of the three used devices described in this report were not provided to cook for evaluation.The report for these devices could not be confirmed.Our evaluation of the returned device confirmed the report of incorrect cutting wire orientation.During the 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 11 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 this observation was not found 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: for two of the three used devices, we could not conduct a complete investigation because these products were not returned for evaluation.A definitive cause for the reported observation could not be determined.For the used device that was returned, 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: ¿note: do not apply manual pressure to tip or cutting wire of the sphincterotome 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 the sphincterotome upon removing the device from the packaging.The user is then instructed to carefully remove the precurved stylet from the 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.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.
 
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Brand Name
FUSION OMNI-TOME
Type of Device
KNS, 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 Key5324019
MDR Text Key34278980
Report Number1037905-2015-00546
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K052051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFS-OMNI
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/31/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Device Age4 MO
Event Location Hospital
Initial Date Manufacturer Received 12/03/2015
Initial Date FDA Received12/23/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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