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

Model Number G34711

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved and the photo provided from the customer confirmed the deformation of the tip of the device.The photo shows the distal tip of the device.A visual inspection of the catheter was performed and the distal tip of the device appears to be distorted/damaged.It is not known at what point the distal tip became distorted/damaged.No section of the sphincterotome device appeared to be missing.The cutting wire and distal tip of the device exhibit evidence of a cautery application (blackening of the cutting wire and blackening of the lumen at the distal tip was noted).The cutting wire securing component has moved proximally inside the lumen, but no portion of the cutting wire or securing component is missing or separated from the catheter.The distal tip appeared to have been distorted or damaged due to an unknown force.Some twisting of the tubing was also noted during the visual examination.During the laboratory evaluation the handle and drive wire functioned as intended and completely bowed the distal tip of the catheter.The breakthrough channel has also been utilized completely and liquid was observed inside of the catheter.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.A lab meeting was held to evaluate the state of the returned device and condition of the distal tip.The review was unable to confirm a manufacturing defect associated with the manufacturing process at distal end of the sphincterotome.The review was also unable to confirm a manufacturing defect associated with damage to the distal tip of the device.Devices released for distribution go through multiple inspections to detect such defects.Inspections include confirmation of adequate tip bowing, a visual inspection to confirm proper forming of the dome shape tip, and proper insertion of the shaping wire at the distal end.Therefore, it is unknown how or at what point the tip of the catheter became damaged/distorted.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: the cause of the deformation of the distal tip of the device is unknown.However, it is possible that the tip was deformed due to contact with an external force.The proposed source of the external force to the catheter is unknown.Evidence of a manufacturing nonconformity was not observed.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 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 Description

During an endoscopic retrograde cholangiopancreatography procedure (ercp), when the sphinctertome was opened it was noticed that a piece of plastic was located on the tip.There was no reportable information at this time.A photo of the device was received on 12-feb-2020 that showed a section of the catheter protruding from the patient end of the device.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

Event Description

The following was initially reported to the fda ¿during an endoscopic retrograde cholangiopancreatography procedure (ercp), when the sphinctertome was opened it was noticed that a piece of plastic was located on the tip.There was no reportable information at this time.A photo of the device was received on 12-feb-2020 that showed a section of the catheter protruding from the patient end of the device.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.¿ the following patient outcome was received 03-mar-2020.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.

• 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
• MDR Report Key: 9774976
• MDR Text Key: 224676267
• Report Number: 1037905-2020-00116
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 10827002347110
• UDI-Public: (01)10827002347110(17)220909(10)W4258600
• Combination Product (y/n): N
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

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 Expiration Date: 09/09/2022
• Device Model Number: G34711
• Device Catalogue Number: FS-OMNI-ACRO-35-450
• Device Lot Number: W4258600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, UNKNOWN MAKE OR MODEL