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-35-260

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our evaluation of the product said to be involved determined there is wire guide coating damage near the distal end.A visual examination of the wire guide showed that the wire guide coating had peeled off between 26.8 cm and 28 cm exposing bare core wire; no portion of the wire guide coating appears to be missing.The sphincterotome associated with this device was included in the return of the device.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A review of the wire guide sub-assembly work order was conducted.A discrepancy or anomaly 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 this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.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 fusion pre-loaded with acrobat wire guides 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: 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 Description

In preparation for a procedure, the user selected a cook fusion pre-loaded with acrobat wire guide sphincterotome.During the preparation stage, the staff noticed that the wire was stripped.The device did not make contact with the patient or endoscope.The following was received (b)(6) 2017: the defect is mid-body of the acrobat wire.There was no reportable information at this time.The device was evaluated on (b)(6) 2017.It was observed that there is core wire exposed between 26.8 cm and 28 cm from the distal end.

• Brand Name: FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 6843624
• MDR Text Key: 86576542
• Report Number: 1037905-2017-00579
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 10827002346939
• UDI-Public: (01)10827002346939(17)190830(10)W3763311
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/05/2017

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
• Device Operator: No Information
• Device Catalogue Number: FS-OMNI-ACRO-35-260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/25/2017
• Device Age: 9 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1