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

Catalog Number	FS-OMNI-ACRO-35-205
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional lot number: w3663832.Concomitant products: cook fusion extraction balloon (fs-8.5-12-15-a).Two (2) of the three (3) reported devices were returned to cook endoscopy for evaluation.Our evaluations of the returned devices confirmed the reports as described in both of the two (2) returned devices.The coating on the wire guide has been damaged at locations ranging from 20 to 25 cm from the distal tip.Each of the returned wire guides have coating damage that exposes the core wires from a range of 7.5 to 11 cm in length.A discrepancy or anomaly that could have contributed to the reported events was not observed during our laboratory analysis.The two potential device history records for one (1) of the wire guides associated with a lot number said to be involved was reviewed.A nonconformity that could be related to the observation reported by the user was found in for coating damage.A review of the specification was conducted and a 100% visual inspection of the coating on the wire guide is performed and inspects for any damage or deformities.This inspection process would have removed any products having this nonconformance prior to distribution.Therefore, a discrepancy or anomaly was not observed with the product that was released for distribution.The device history record for the lot numbers said to be involved was reviewed.A discrepancy or anomaly was not observed with the products that were released for distribution.A definitive cause for the reported observations could not be determined because the condition of the products 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.The instructions for use advise the user that the wire guide should be kept wet for best results.The instructions for use describe the appropriate flushing techniques for use of these coated wire guides.These techniques described include, flushing the endoscope accessory channel and/or lumen of accessory device with sterile water before wire guide insertion.If these flushing techniques are not followed or inadequate flushing occurs, this can contribute to wire guide coating damage.Prior to distribution, all fusion 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 lots said to be involved met all manufacturing requirements prior to shipment.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
This report summarizes three (3) malfunction events.A review of the events indicated that during endoscopic retrograde cholangiopancreatography (ercp) procedures, the physicians used cook fusion pre-loaded with acrobat calibrated tip wire guides.During the procedures, the users experienced coating damage to the pre-loaded wire guide.These reports were received from various sources on various dates.All three (3) events involved patients with no patient consequences.One (1) of the patients was reported to be female, and also had stones in the common bile duct.
Additional Manufacturer Narrative
Manufacturer exemption number: e2015051.This mdr report is part of the 227 pilot program.Additional lot number: w3663832.Continued from section d.11.: cook fusion extraction balloon (fs-8.5-12-15-a).Continued from section h.6.: (b)(4).Two (2) of the three (3) reported devices were returned to cook endoscopy for evaluation.Our evaluations of the returned devices confirmed the reports as described in both of the two (2) returned devices.The coating on the wire guide has been damaged at locations ranging from 20 to 25 cm from the distal tip.Each of the returned wire guides have coating damage that exposes the core wires from a range of 7.5 to 11 cm in length.A discrepancy or anomaly that could have contributed to the reported events was not observed during our laboratory analysis.The two potential device history records for one (1) of the wire guides associated with a lot number said to be involved was reviewed.A nonconformity that could be related to the observation reported by the user was found in for coating damage.A review of the specification was conducted and a 100% visual inspection of the coating on the wire guide is performed and inspects for any damage or deformities.This inspection process would have removed any products having this nonconformance prior to distribution.Therefore, a discrepancy or anomaly was not observed with the product that was released for distribution.The device history record for the lot numbers said to be involved was reviewed.A discrepancy or anomaly was not observed with the products that were released for distribution.A definitive cause for the reported observations could not be determined because the condition of the products 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.The instructions for use advise the user that the wire guide should be kept wet for best results.The instructions for use describe the appropriate flushing techniques for use of these coated wire guides.These techniques described include, flushing the endoscope accessory channel and/or lumen of accessory device with sterile water before wire guide insertion.If these flushing techniques are not followed or inadequate flushing occurs, this can contribute to wire guide coating damage.Prior to distribution, all fusion 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 lots said to be involved met all manufacturing requirements prior to shipment.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
This report summarizes three malfunction events.A review of the events indicated that during endoscopic retrograde cholangiopancreatography (ercp) procedures, the physicians used cook fusion pre-loaded with acrobat calibrated tip wire guides.During the procedures, the users experienced coating damage to the pre-loaded wire guide.These reports were received from various sources on various dates.All three (3) events involved patients with no patient consequences.One (1) of the patients was reported to be female, and also had stones in the common bile duct.

• Brand Name: FUSION® 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: 5609711
• Report Number: 1037905-2016-00114
• Device Sequence Number: 834105
• Product Code: KNS
• UDI-Device Identifier: 10827002346014
• UDI-Public: (01)10827002346014(17)181016(10)W3631240
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K052051
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2016

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: FS-OMNI-ACRO-35-205
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/10/2016
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2016
• Supplement Report FDA Received Date: 06/15/2016
• 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: OLYMPUS ENDOSCOPE, UNKNOWN MODEL