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

Catalog Number FS-25M-35

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: cook acrobat 2 calibrated tip wire guide, awg2-35-260.Fusion wire guide locking device, fs-wl-o-s.Erbe electrosurgical generator.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 12 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 observed at the distal end.The wire guide pin vise was included in the return.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.A nonconformity that could be related to the observation reported by the user was found in the device history record.The device goes through several inspections in manufacturing, final quality control, and packaging departments prior to shipment in an effort to ensure proper orientation.This inspection process would have removed any products having this nonconformance prior to distribution.Therefore, a discrepancy or anomaly was not observed with the product that was released for distribution.It is unknown how or at what point the tubing of the complaint device became twisted at the distal end.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 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 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 packaging, 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 fusion 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 Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion triple lumen sphincterotome.There was an orientation problem.The following additional information was provided on 11/30/2017: there was an orientation problem resulting in an inability to cannulate.

• Brand Name: FUSION TRIPLE LUMEN SPHINCTEROTOME
• 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 Key: 7138736
• MDR Text Key: 96068409
• Report Number: 1037905-2017-00776
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002315334
• UDI-Public: (01)00827002315334(17)190615(10)W3726879
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2017

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 Number: FS-25M-35
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/29/2017
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1