MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number FS-OMNI-35-260

Device Problems Break (1069); Material Separation (1562)

Patient Problems Unspecified Infection (1930); Bowel Perforation (2668)

Event Date 10/12/2015

Event Type  Injury  

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.Because the device was not returned, the exact failure of the cutting wire cannot be determined.Typically, actual cutting wire breakage occurs during a cutting attempt and when current is being applied.In the case described, the sphincterotomy was already performed and the physician was attempting cannulation.During cannulation, no current is applied but the tip may be bowed several times in an attempt to reach the desired location in the bile duct.Therefore, it is believed the cutting wire securing component separated from the catheter during the stated observation by the user.A review of the device history record could not be conducted because the lot number was not provided.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 not to over flex or bow the tip beyond 90 degrees, as this may damage the sphincterotome.This type of damage 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 the sphincterotome to influence orientation, as this may result in damage to device.¿ if the elevator of the endoscope remains in the closed and up position when retraction of the sphincterotome is attempted and additional pressure is applied, this could have contributed to separation of the catheter and cutting wire securing component.The instructions for use caution the user the elevator should remain open and down when advancing or retracting the sphincterotome.This activity will aid in device preservation.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 to uncoil and straighten the sphincterotome upon removing the device from the packaging.The user is then instructed to carefully remove the precurved stylet from the 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 omni-tome pre-loaded 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.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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome.There was nothing precluding the procedure on history or physical examination.Informed consent was obtained with the benefits, risks and alternatives for the procedure explained.The patient tolerated the procedure well.The major papilla was located in the second part of the duodenum.It was small in size.The pancreatic duct was cannulated via the major papilla, but no contrast was injected.Bile duct cannulation via major papilla was unsuccessful despite pre-cut access sphincterotomy, small amount of sub-mucosal contrast injection noted.Upon withdrawal of sphincterotome from ampulla, the cutting wire of the sphincterotome was noted to have come apart at the distal end, leaving a loose wire in direct contact with tissue.The procedure was immediately aborted.

• Brand Name: FUSION OMNI-TOME PRE-LOADED 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: 5307324
• MDR Text Key: 33801002
• Report Number: 1037905-2015-00533
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-OMNI-35-260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: OLYMPUS TJF-260 ENDOSCOPE
• Patient Age: 49 YR