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

Model Number	G34778
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: fusion® quattro® extraction balloon (fs-qeb-xl-a).Occupation: non-healthcare professional.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The subassembly device history record for the wire guide subassembly lot number said to be involved was reviewed.A nonconformance was observed that could be related to the reported observation.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide 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.The functional test includes bowing the sphincterotome to ensure proper function.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.® preloaded with acrobat wire guide sphincterotome.Ercp stone extraction went okay with an extraction balloon.After the procedure (was ready), it was determined the coating from the wire guide detached.Nothing was left in the body and the wire was disposed of.The coating damage occurred at 15 cm behind the patient end for 20 cm.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 9153611
• Report Number: 1037905-2019-00575
• Device Sequence Number: 3123366
• Product Code: KNS
• UDI-Device Identifier: 10827002347783
• UDI-Public: (01)10827002347783(17)220606(10)W4223697
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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 Expiration Date: 06/06/2022
• Device Model Number: G34778
• Device Catalogue Number: DASH-ACRO-35-450
• Device Lot Number: W4223697
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1