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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
Model Number G31903
Device Problems Material Separation (1562); Use of Device Problem (1670)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 03/14/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: erbe electrosurgical generator; cook acrobat 2 calibrated tip wire guide, awg2-35-260.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 condition of the device prohibited a functional test of the device 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 shows 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: responses to additional questions indicated that the distal end of the device was formed manually.The instructions for use advise the user: "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." this is the most likely cause for the reported observation.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: 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.Additional comments regarding this report: based on the information provided that the sphincterotome tip was manually formed, 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) with endoscopic sphincterotomy (est), the physician used a cook fusion omni-tome sphincterotome.The physician inserted the sphincterotome into the endoscope with a cook acrobat 2 calibrated tip wire guide, and tried to access the ampulla.The physician found that the cutting wire was broken.A new fusion omni-tome sphincterotome was used.There was no reportable information at this time.Per the cook sales representative on 21-mar-2019: it looked like the cutting wire broke in one (1) location with no detachment, but it was not clear.There was no reportable information at this time.The device was returned on 10-apr-2019 and the evaluation of the device determined that the cutting wire securing component had separated and a portion is missing.The initial reported stated that a section of the device did not remain inside the patient¿s body; however, the location of the missing portion is unknown.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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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 (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 Key8577964
MDR Text Key152917552
Report Number1037905-2019-00219
Device Sequence Number1
Product Code KNS
UDI-Device Identifier00827002319035
UDI-Public(01)00827002319035(17)210917(10)W4120532
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
K052051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 03/18/2019
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 Expiration Date09/17/2021
Device Model NumberG31903
Device Catalogue NumberFS-OMNI
Device Lot NumberW4120532
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/10/2019
Initial Date FDA Received05/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2018
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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