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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
Model Number G34693
Device Problems Material Frayed (1262); Peeled/Delaminated (1454)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 05/30/2019
Event Type  malfunction  
Manufacturer Narrative
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 contains a nonconformance that could potentially be related to wire guide damage. 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 coating damage. Prior to distribution, all fusion pre-loaded acrobat with wire guides are subjected to a visual inspection 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 sphincterotome. The wire stripped its coating. The procedure was proceeding smoothly until a pigtail stent was deployed. This proved to be much harder than anticipated, although it was eventually deployed. Upon inspection of the wire guide at the end of the case, it was observed that the distal coating of approximately 10 cm had sheared off the base wire. 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.
 
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Brand NameFUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE
Type of DeviceKNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
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 Key8726942
MDR Text Key152203430
Report Number1037905-2019-00342
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
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/22/2022
Device Model NumberG34693
Device Catalogue NumberFS-OMNI-ACRO-35-260
Device Lot NumberW4206238
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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