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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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COOK ENDOSCOPY FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number G56103
Device Problem Peeled/Delaminated (1454)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: our evaluation of the product said to be involved confirmed the report. The wire guide was returned without the associated sphincterotome. During a visual examination of the wire guide, damage was observed at the distal end. A section of wire guide coating approximately 4. 3 cm long detached from the distal end of the wire guide causing the coil spring to unravel and exposing bare core wire. The detached portion of wire guide coating is hanging from the unraveled coil spring at the distal tip of the device. Due to the condition of the returned device it cannot be determined if any sections of the coating are 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 lot number said to be involved was reviewed. The device history record contains nonconformances that could potentially be related to wire guide damage near the distal end. The device goes through various inspections prior to leaving the facility. These inspections would have removed any nonconforming devices prior to distribution. 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 prior to use testing conditions could not be duplicated in the laboratory setting. This limits our ability to conclusively determine a cause. 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 instruct the user to do the following: "for best results, wire guide should be kept wet. " failure to flush the wire guide can result in damage to the wire guide. 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 omni-tome pre-loaded sphincterotomes 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: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. 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
Prior to an endoscopic retrograde cholangiopancreatography (ercp) the physician selected a fusion omni-tome pre-loaded sphincterotome. The device came with a frayed wire. They were able to use the sphincterotome portion of the device, but had to replace the pre-loaded sphincterotome wire guide. The wire guide of the device was received for evaluation on 20-aug-2020. A portion of the black coating at the tip has come off. It is still attached to the core wire but the core wire is unraveled [subject of the report]. This occurred prior to patient contact. There was no impact to the patient.
 
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Brand NameFUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
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 Key10488823
MDR Text Key205515995
Report Number1037905-2020-00356
Device Sequence Number1
Product Code KNS
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
Type of Report Initial
Report Date 09/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG56103
Device Catalogue NumberFS-OMNI-21-260
Device Lot NumberW4360861
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2020
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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