MAUDE Adverse Event Report: COOK ENDOSCOPY TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G22583
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued from concomitant products: cook tracer metro direct wire guide, metii-35-480; valleylab surgistat electrosurgical generator.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.A photograph was provided and reviewed.An evaluation of the photograph provided by the user confirmed the report on incorrect cutting wire orientation.The photo provided is in the endoscopic view and the cutting wire of the sphincterotome is oriented in the 6 o'clock direction.Without return of the complaint device further investigation could not be performed.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.Incorrect cutting wire orientation can occur if the distal end of the catheter is shaped manually.This sphincterotome catheter is precurved and is provided with a precurved 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 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: "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 tri-tome pc triple lumen 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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used two (2) cook tri-tome pc triple lumen sphincterotomes.As reported to customer relations: "at the time, while trying to cannulate, the first sphincterotome had bad orientation [incorrect cutting wire orientation].The asistant threw it away and opened another brand new sphincterotome, which had the same problem [incorrect cutting wire orientation].Finally, the third sphincterotome worked.".
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used two (2) cook tri-tome pc triple lumen sphincterotomes.As reported to customer relations: "at the time, while trying to cannulate, the first sphincterotome had bad orientation [incorrect cutting wire orientation].The assistant threw it away and opened another brand new sphincterotome, which had the same problem [incorrect cutting wire orientation].Finally, the third sphincterotome worked." a section of the device did not remain inside the patient¿s body.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.
Additional Manufacturer Narrative
Correction to event.This report is being sent to correct section b description of event to include the patient outcome.Concomitant medical products: cook tracer metro direct wire guide, metii-35-480.Valleylab surgistat electrosurgical generator.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.A photograph was provided and reviewed.An evaluation of the photograph provided by the user confirmed the report on incorrect cutting wire orientation.The photo provided is in the endoscopic view and the cutting wire of the sphincterotome is oriented in the 6 o'clock direction.Without return of the complaint device further investigation could not be performed.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.Incorrect cutting wire orientation can occur if the distal end of the catheter is shaped manually.This sphincterotome catheter is precurved and is provided with a precurved 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 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: "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 tri-tome pc triple lumen 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.

• Brand Name: TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7660726
• Report Number: 1037905-2018-00301
• Device Sequence Number: 19335961
• Product Code: KNS
• UDI-Device Identifier: 00827002225831
• UDI-Public: (01)00827002225831(17)210124(10)W4017790
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K901443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2021
• Device Model Number: G22583
• Device Catalogue Number: TRI-20
• Device Lot Number: W4017790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS TJF-150 ENDOSCOPE
• Patient Age: 53 YR
• Patient Weight: 72