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-21-480
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: an evaluation of the returned device confirmed the report on wire guide coating damage.The associated sphincterotome was not included in the return.The wire guide has coating damage near the distal end.Coating has peeled exposing bare core wire between 1.8 cm to 4.2 cm from the distal end and the coating has bunched up at 1.5 cm from the distal end.A small portion of the coating was removed at the proximal end of the coating to determine if the coil spring was still present.This review found the coil spring to be present in the intended location, however due to the condition of the coating on the returned device, it cannot be determined if any section of the coating is missing.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.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 this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use advise the user: "for best results, wire guide should be kept wet." the technique described includes flushing the endoscope accessory channel and/or lumen of accessory device with sterile water before wire guide insertion.If this flushing technique is not followed, this can contribute to wire guide coating damage.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.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 a cook d.A.S.H.Dometip double lumen sphincterotome.The wire coating began to strip off near the distal end.No portion came off in the patient.The procedure was completed with another wire.

• 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: 7309097
• Report Number: 1037905-2018-00079
• Device Sequence Number: 877500
• Product Code: KNS
• UDI-Device Identifier: 00827002257900
• UDI-Public: (01)00827002257900(17)191026(10)W3782124
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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-21-480
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/02/2018
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1