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

Catalog Number	DASH-ACRO-25-450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	01/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: erbe electrosurgical generator.Investigation evaluation: our evaluation of the returned device confirmed the report.The cutting wire has broken and approximately 13 mm of the cutting wire remains attached on the distal side.Due to the break in the cutting wire, the sphincterotome will not respond to handle manipulation and is no longer operational.A section of the cutting wire has detached and was not returned with the device, estimated to be 12 mm in length.There is a ball of melted wire at the proximal cutting wire hole in the catheter.The ball of melted wire is not enough to account for 12 mm of missing cutting wire.The cutting wire exhibits evidence of a cautery application (blackening of the cutting wire was noted).The wire guide pre-loaded in the sphincterotome was not included in the return of the device.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.A broken cutting wire can occur if the tip of the device 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." cutting wire breakage can occur if the handle is manipulated with the catheter in a coiled position or with the precurved stylet inside the cannulating tip.The instructions for use advise the user to: ¿upon removing device from package, uncoil and straighten sphincterotome." the user is then instructed to "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." cutting wire breakage can also occur if the cutting wire makes contact with the endoscope when electrosurgical current is applied to perform the sphincterotomy.The instructions for use caution the user: "when applying current, ensure cutting wire is completely out of endoscope." the instructions caution the user: ¿contact of cutting wire with endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire and/or damage to endoscope." if the sphincterotome is used with excessive electrosurgical current settings provided by the electrosurgical unit, this can contribute to cutting wire breakage.The instructions for use direct 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." 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 contribute to cutting wire breakage.The instructions for use caution the user: "elevator should remain open/down when advancing or retracting sphincterotome." this activity will aid in device preservation.Prior to distribution, all dash pre-loaded with acrobat wire guide 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 and this represents an isolated occurrence.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 a cook d.A.S.H.Preloaded with acrobat wire guide.The product was pushed through the working channel without first manipulating the tip, then the wire was pulled to raise the point, and the cutting wire was torn [cutting wire broke].There was no reportable information at this time.The device was received for evaluation on 2/14/17, and it was noted that the cutting wire was broken and a section of the cutting wire is missing.

• Brand Name: D.A.S.H.® 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: 6394846
• Report Number: 1037905-2017-00095
• Device Sequence Number: 1002521
• Product Code: KNS
• UDI-Device Identifier: 10827002347783
• UDI-Public: (01)10827002347783(17)190815(10)W3758293
• Combination Product (Y/N): N
• PMA/510(K) Number: K901443
• 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): 03/10/2017

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-ACRO-25-450
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/23/2017
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/10/2017
• 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: OLYMPUS TJF-160-VR ENDOSCOPE