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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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WILSON-COOK MEDICAL INC CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number G25801
Device Problem Material Separation (1562)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2022
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) # k172665. Investigation evaluation: a product evaluation was not performed in response to this report because the product 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. 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. " 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 cannulatome ii pc double lumen 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 and this represents an unusual occurrence. 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) procedure, the physician used a cook cannulatome ii pc double lumen sphincterotome. It was initially reported that during ercp the cutting wire of the papillotome snapped. The cutting wire tore apart after being tensed two times. It was additionally reported that the wire pointed 90 degrees upwards and the doctor had problems to pull the ct out of the duct. She finally managed to remove it and nothing stayed inside [the patient]. There was no reportable information at this time. Per communication received on 08 march 2022: cutting wire anchor disconnected at the patient end of device and detached. It was reported that a section of the device did not remain inside the patient¿s body; however, further information indicates that a portion detached. 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 NameCANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME
Type of DeviceKNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
WILSON-COOK MEDICAL INC
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
sabrina o'brien
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key14014243
MDR Text Key290159731
Report Number1037905-2022-00158
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG25801
Device Catalogue NumberCT-30
Device Lot NumberW4527162
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2021
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: 04/05/2022 Patient Sequence Number: 1
Treatment
ERBE VIO200D ELECTROSURGICAL GENERATOR; OLYMPUS TJF-Q190V DUODENOSCOPE
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