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	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: (b)(4) vio 200 electrosurgical unit.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.There is approximately 7.6 cm of bare core wire at 19 cm to 26.6 cm from the distal end.A portion of the covering is folded over on itself toward the distal end and measures approximately 2.5 cm.A similar portion of the covering is folded over itself toward the proximal end and measures approximately 3.5 cm.No kinks are found along the wire guide.Since the length of coating folded over on each side of the bare wire is similar to the length of bare wire, it is not likely any of the coating detached.In addition, a cook acrobat wire guide from the laboratory (not the complaint device) was advanced through the wire guide port of the returned sphincterotome, and there was no resistance during wire guide advancement.The wire guide exited the distal tip of the device.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 for this product line instruct the user to: "flush injection port with sterile water.For best results, wire guide should be kept wet." this activity will aid in optimal performance of the wire guide.Failure to flush the endoscope channel can result in damage to the wire guide.Prior to distribution, all d.A.S.H.Pre-loaded with acrobat wire guides are subjected to a visual inspection 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.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook d.A.S.H.Pre-loaded with acrobat wire guide.The tip of the wire guide got [a] tear [coating damage at distal end].Subsequently, the device was removed from the patient [device was taken out due to the coating damage].

• 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: 6048400
• Report Number: 1037905-2016-00421
• Device Sequence Number: 10847430
• Product Code: KNS
• UDI-Device Identifier: 10827002347790
• UDI-Public: (01)10827002347790(17)190818(10)W3759519
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2016

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: DASH-ACRO-25-450
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/25/2016
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2016
• Initial Report FDA Received Date: 10/21/2016
• 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: (B)(4) ED 3490 TK ENDOSCOPE
• Patient Age: 40 YR
• Patient Weight: 65