MAUDE Adverse Event Report: COOK ENDOSCOPY D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number	DASH-35-480
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant product: endostat ii electrosurgical generator.Investigation evaluation: both products involved were returned and evaluated.The results of the evaluation are as follows: device one - our laboratory evaluation of the product said to be involved confirmed the cutting wire securing component located near the distal end of the sphincterotome has disconnected from the catheter.The cutting wire is intact and remains securely attached to the sphincterotome at the proximal end.However, due to the catheter and securing component disconnection, the distal end of the cutting wire is no longer connected to the sphincterotome catheter at the distal end.No section of the sphincterotome device is missing.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.Device two- our laboratory evaluation of the product said to be involved confirmed the cutting wire securing component located near the distal end of the sphincterotome has disconnected from the catheter.The cutting wire is intact and remains securely attached to the sphincterotome at the proximal end.However, due to the catheter and securing component disconnection, the distal end of the cutting wire is no longer connected to the sphincterotome catheter at the distal end.No section of the sphincterotome device is missing.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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: "do not over flex or bow tip beyond 90 degrees, as this may damage or cause cutting wire to break." 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 sphincterotome to influence orientation, as this may result in damage to device.¿ if the elevator of the endoscope remains in the closed/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: "elevator should remain open/down when advancing or retracting 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: "upon removing device from package, uncoil and straighten sphincterotome."the user is then instructed: "carefully remove precurved stylet wire 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 the sphincterotome and render it inoperable." the instructions for use advise the user: "before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode.Ensure a proper path from patient return electrode to electrosurgical unit is maintained through procedure." prior to distribution, all d.A.S.H.Dometip double lumen 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.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 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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used two (2) cook dash dometip double lumen sphincterotomes.The cutting wire was not intact on both devices [cutting wire breaks in one location without detachment].Another device was used to complete the procedure.The complaint did not contain reportable information at this time.The following additional information was received from the cook area representative on 1/19/17: "i spoke with several staff about this.They were using an old endostat ii for the sphincterotomy.Their current conmed generator is broken and had not used the endostat ii for an ercp before.They were not sure for the actual settings to use.They did not feel like it was cutting with the settings they were using.One person said it was set on pure cut and 35 watts.Another person said it was pure cut and 40 watts.The limited information they had was to use 40 to 50 watts with purecut.They did check the cutting wire before on each dash and it was intact.When i picked them up today, the cutting wire had pulled out of the distal end of the catheter [cutting wire securing component/anchor separates from catheter].The wire does not appear to be broken.It makes me wonder if they should have used higher watts.".

• Brand Name: D.A.S.H. DOMETIP DOUBLE 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: 6326871
• Report Number: 1037905-2017-00053
• Device Sequence Number: 11154150
• Product Code: KNS
• UDI-Device Identifier: 00827002256668
• UDI-Public: (01)00827002256668(17)190623(10)W3734244
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K901443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2017

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: DASH-35-480
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 02/13/2017
• 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: OLYMPUS TJF ENDOSCOPE