MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION® PRE-LOADED WITH ACROBAT 2 WIRE GUIDE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G57302
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k172288.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.Separation of the cutting wire securing component and the catheter can occur if the tip of the sphincterotome is over flexed.The instructions for use caution the user with the following comment: ¿do not over flex or bow the tip beyond 90 degrees, as this may damage or cause the cutting wire to break.¿ other factors that can contribute to separation of the cutting wire securing component and the catheter include manipulating the handle with the catheter in a coiled position or with the precurved stylet inside the cannulating tip.The instructions for use contain the following precaution: "do not exercise the handle while the device is coiled or the precurved stylet is in place, as this may cause damage to the sphincterotome and render it inoperable." the instructions for use advise the user with the following statement: ¿upon removing the device from the package, uncoil and straighten the sphincterotome.Carefully remove the precurved stylet from the cannulating tip.¿ prior to distribution, all fusion® pre-loaded with acrobat 2 wire guide 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) procedure, the physician used a cook fusion® pre-loaded with acrobat 2 wire guide.It was reported that the sphincterotome was retrieved and the physician tried to reinsert into the wire lock.The dislocated cutting wire refused to be pushed through the wire lock.After checking the tip it was realized the a part of the cutting wire was dislocated.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.
Event or Problem Description
This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference the additional information section for this justification.
Additional Manufacturer Narrative
This mdr follow up report is being submitted to cancel the initial report submitted relating to this event.An emdr report was initially sent on 16 jan 2023, based on the initial information received that the cutting wire anchor disconnected at the patient end of the device.The device was received for evaluation on 23 jan 2023.Our evaluation of the returned device determined that the anchor has moved approximately 4mm, splitting the lumen, and causing a section of the anchor to protrude through the catheter and the anchor has not separated from the catheter.No portion of the cutting wire or securing component is missing.This malfunction has not historically caused or contributed to a death or serious injury.Based on the device evaluation and further quality and medical evaluation this incident no longer meets the reporting criteria of an fda mdr report.

• Brand Name: FUSION® PRE-LOADED WITH ACROBAT 2 WIRE GUIDE
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 16174282
• Report Number: 1037905-2023-00026
• Device Sequence Number: 2672940
• Product Code: KNS
• UDI-Device Identifier: 10827002573021
• UDI-Public: (01)10827002573021(17)240802(10)W4501220
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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 Expiration Date: 08/02/2024
• Device Model Number: G57302
• Device Catalogue Number: FS-OMNI-AWG2-35-260
• Device Lot Number: W4501220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS DUODENOSCOPE
• Patient Sex: Female
• Patient Weight: 55 KG