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-35-205
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The breakthrough channel has been utilized from the zip port to approximately 105 cm proximal to the zip port.The outer edges of the channel are rippled.A functional test was conducted to test the remainder of the zip channel.During our laboratory analysis, the sphincterotome was prepped and 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-160vr).The breakthrough channel was utilized the full length of the channel.Resistance was encountered therefore confirming difficulty with zip exchange.After the exchange, the outer edges of the channel were noted to be rippled and torn.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 corrective action has been initiated to reduce occurrences of this nature.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all fusion pre-loaded with acrobat wire guides 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: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.A review of the complaint history was conducted.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
On (b)(6) 2016, the following information was received: during an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion pre-loaded with acrobat wire guide.During the peel away [exchange] of the sphincterotome with the wire guide, it had created a tear in the sheath, therefore it was impossible to pull out the wire guide without pulling the entire catheter.On (b)(6) 2016 we received the following: the user lost wire guide access to the papilla unintentionally.

• 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: 5939713
• Report Number: 1037905-2016-00348
• Device Sequence Number: 16265289
• Product Code: KNS
• UDI-Device Identifier: 10827002346014
• UDI-Public: (01)10827002346014(17)190302(10)W3685610
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/17/2016

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-35-205
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2016
• Initial Report FDA Received Date: 09/09/2016
• 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: FUJINON ENDOSCOPE, UNKNOWN MODEL