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U.S. Department of Health and Human Services

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

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COOK ENDOSCOPY FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Catalog Number FS-OMNI-ACRO-35-260
Device Problem Peeled/Delaminated (1454)
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.
 
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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 Key6843624
MDR Text Key86576542
Report Number1037905-2017-00579
Device Sequence Number1
Product Code KNS
UDI-Device Identifier10827002346939
UDI-Public(01)10827002346939(17)190830(10)W3763311
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052051
Number of Events Reported1
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 NumberFS-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 Date05/25/2017
Device Age9 MO
Event Location Hospital
Initial Date Manufacturer Received 08/31/2017
Initial Date FDA Received09/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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