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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-35-205
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2015
Event Type  malfunction  
Manufacturer Narrative
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 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.The instructions 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 this coated wire guide.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 guide 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
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion pre-loaded with acrobat wire guide.The wire guide shredded on the bridge of the endoscope [coating damage at the distal end] necessitating a change of wire in order to complete the procedure.
 
Manufacturer Narrative
Investigation evaluation: our evaluation of the product said to be involved confirmed the damage.There is wire guide coating damage near the distal end of the product.The coil spring is still attached to the distal end of the wire guide.Near the 10 cm mark on the distal end the coating is peeled on the core wire exposing approximately 1.5 cm.The material appears to be intact without anything missing.A product specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the subassembly wire guide associated with the lot number said to be involved was reviewed.A nonconformity that could be related to the observation reported by the user was found in the device history record for coating damage.A review of the specification was conducted and a 100% visual inspection of the coating on the wire guide was performed and inspected 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 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 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 this coated wire guide.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 guide 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.
 
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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 Key5165099
MDR Text Key28809003
Report Number1037905-2015-00440
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K052051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Followup
Report Date 09/24/2015
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 Health Professional
Device Catalogue NumberFS-OMNI-ACRO-35-205
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/24/2015
Device Age3 MO
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/21/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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