MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number	FS-OMNI-ACRO-35-450
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2017
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 evaluation of the photos provided from the customer show incorrect orientation of the sphincterotome in the endoscopic view and confirmed the complaint of incorrect orientation.However, without return of the complaint device, further investigation cannot be completed.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 in an attempt 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."the user is then instructed to "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." information was provided that prior to use poor orientation was observed at the tip.The instructions for use advise the user: "if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." prior to distribution, all fusion pre-loaded with acrobat wire guide 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.Additional comments regarding this report: based on the information provided that poor orientation was observed prior to use and the device was used, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion with preloaded acrobat wire guide.When they opened the package and removed the stylet, poor orientation at the tip of the sphincterotome was seen.They tested it [the device] and saw in the papilla the bad orientation [the cutting wire oriented incorrectly to the papilla].

• Brand Name: FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE
• 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: 6322494
• Report Number: 1037905-2017-00048
• Device Sequence Number: 16335661
• Product Code: KNS
• UDI-Device Identifier: 10827002347110
• UDI-Public: (01)10827002347110(17)191214(10)W3806433
• Combination Product (Y/N): N
• PMA/510(K) Number: K052051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: FS-OMNI-ACRO-35-450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2017
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2017
• Initial Report FDA Received Date: 02/10/2017
• 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: PENTAX DUODENOSCOPE, UNKNOWN MODEL