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

Model Number	G22554
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Improper 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 a cook tri-tome pc triple lumen sphincterotome.The physician, very experienced and familiar user of cook tri-tome pc triple lumen sphincterotomes, attempted sphincterotomy.[the attempted sphincterotomy] failed because of inconvenient orientation [incorrect cutting wire orientation].Despite the three-dimensional forming stylet, the orientation was very bad.Instead of 12 o¿ clock, the sphincterotome faced 3 o¿ clock (subject of this report).The physician removed the sphincterotome and completed the process using another sphincterotome.The physician complains that the same incident has happened several times with the tri-25 (mdr report 1037905-2018-00117) and tri-30 (mdr report 1037905-2018-00118).
Additional Manufacturer Narrative
Investigation evaluation: an evaluation of the returned device confirmed the report on 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 10 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).The sphincterotome catheter was subjected to a close visual examination and twisting of the tubing was not observed at the distal end.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 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
The following was reported to the fda on 03/27/2018: "during an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook tri-tome pc triple lumen sphincterotome.The physician, very experienced and familiar user of cook tri-tome pc triple lumen sphincterotomes, attempted sphincterotomy.[the attempted sphincterotomy] failed because of inconvenient orientation [incorrect cutting wire orientation].Despite the three-dimensional forming stylet, the orientation was very bad.Instead of 12 o¿ clock, the sphincterotome faced 3 o¿ clock (subject of this report).The physician removed the sphincterotome and completed the process using another sphincterotome.The physician complains that the same incident has happened several times with the tri-25 (mdr report 1037905-2018-00117) and tri-30 (mdr report 1037905-2018-00118)." the device was returned on 03/27/2018 for evaluation.On 03/28/2018 additional information was received.According to the physician, the incorrect cutting wire orientation was found prior to bowing the distal end.

• 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: 7375659
• Report Number: 1037905-2018-00116
• Device Sequence Number: 1067964
• Product Code: KNS
• UDI-Device Identifier: 00827002225541
• UDI-Public: (01)00827002225541(17)201128(10)W4000413
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K901443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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 Model Number: G22554
• Device Catalogue Number: TRI-25
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/23/2018
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1