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

Model Number	G55814
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion omni-tome pre-loaded sphincterotome.It was initially reported that there was a faulty wire during sphincterotomy.The cutting wire on the sphincterotome broke after 2 successful cuts.No harm to patient.There was no reportable information at this time.Per reply with image received on (b)(6) 2022 the cutting wire anchor disconnected at the patient end of device.[subject of report].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.
Additional Manufacturer Narrative
Pma/510(k) # k172288.Investigation evaluation: a product evaluation was performed only by the picture provided with this report because the products said to be involved were not provided to cook for evaluation.The lot number was not provided.The picture provided shows the distal end of the device.The cutting wire securing component (anchor) has separated from the catheter near the distal end.The distal end of the cutting wire is no longer connected to the sphincterotome catheter at the distal end.The securing component has a longer section and a shorter section therefore no part of the device appears to be missing.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 omni-tome pre-loaded sphincterotomes are subjected to a visual inspection to ensure device integrity.The visual inspection ensures the product is free of kinks.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.
Additional Manufacturer Narrative
Pma/510(k) # k172288.Investigation evaluation: the product said to be involved was returned in clear plastic bag.The preloaded wire guide was not returned with the sphincterotome.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.A picture was provided and reviewed.The picture shows the distal end of the device.The cutting wire securing component (anchor) has separated from the catheter near the distal end.Our laboratory evaluation of the product said to be involved and picture provided confirmed the cutting wire securing component located near the distal end of the sphincterotome has disconnected from the catheter.Due to the catheter and securing component disconnection, the distal end of the cutting wire is no longer connected to the sphincterotome catheter at the distal end.The securing component has a longer section measuring 3 mm and a shorter section measuring 2 mm therefore no part of the device is missing.The cutting wire also exhibits slight evidence of a cautery application (blackening of the cutting wire was noted).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: our visual evaluation of the returned device confirmed the report.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.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 omni-tome pre-loaded sphincterotomes are subjected to a visual inspection to ensure device integrity.The visual inspection ensures the product is free of kinks.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.

• Brand Name: FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
• 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: 15414425
• Report Number: 1037905-2022-00509
• Device Sequence Number: 14857959
• Product Code: KNS
• UDI-Device Identifier: 00827002558144
• UDI-Public: (01)00827002558144(17)250408(10)W4583711
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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: 04/08/2025
• Device Model Number: G55814
• Device Catalogue Number: FS-OMNI-35-260
• Device Lot Number: W4583711
• 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: 08/19/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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: ERBE ELECTROSURGICAL GENERATOR; OLYMPUS TJF V DUODENOSCOPE
• Patient Sex: Unknown