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

Catalog Number	FS-OMNI-35
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: erbe electrosurgical generator.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The initial report indicated the distal tip of the catheter was twisted.A visual inspection of the catheter was performed and it does not appear to be twisted but the distal tip of the device is distorted/damaged.It is not known at what point the distal tip became distorted/damaged.No section of the sphincterotome device is missing.A product discrepancy or anomaly that could have contributed to this reported occurrence 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.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.Damage to the catheter tip can occur if the distal end of the catheter is shaped manually.This sphincterotome catheter is precurved and is provided with a precurved stylet in the distal tip of the catheter.This obviates the need for manual formation.The instructions for use contain the following comment: ¿note: do not apply manual pressure to tip or cutting wire of sphincterotome in an attempt to influence orientation, as this may result in damage to device.¿ damage to the catheter tip can also occur if the precurved stylet is forcefully removed.The instructions for use instruct the user: ¿upon removing device from package, uncoil and straighten sphincterotome.Carefully remove precurved stylet from cannulating tip." if the elevator of the endoscope remains in the closed/up position when retraction of the sphincterotome is attempted and if additional pressure is applied, this could contribute to damage at the catheter tip.The instructions for use caution the user: "elevator should remain open/down when advancing or retracting sphincterotome." this activity will aid in device preservation.The instructions for use also advise the user to: ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." prior to distribution, all fusion omni-tome pre-loaded sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity.The functional test includes bowing the sphincterotome to ensure the distal end responds to handle manipulation.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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omn-tome preloaded sphincterotome.The sphinctertome was very stiff passing through the scope and when it came through the end of the scope at the bile duct, it was twisted and bent.It was pulled out of the scope.The following clarification was received on 2/23/17: the catheter was bent/twisted but cutting wire remains correctly oriented.There was no reportable information at this time.During evaluation of the returned device on 3/15/17, it was observed that the tip of the catheter is distorted and is protruding.

• Brand Name: FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6473125
• Report Number: 1037905-2017-00156
• Device Sequence Number: 849908
• Product Code: KNS
• UDI-Device Identifier: 00827002319110
• UDI-Public: (01)00827002319110(17)191222(10)W3809850
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: FS-OMNI-35
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/17/2017
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS ENDOSCOPE (UNKNOWN MODEL)