MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION TRIPLE LUMEN NEEDLE KNIFE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number FS-PRECUT

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation evaluation: our evaluation of the returned device confirmed the report of the needle knife detaching from the distal end of the device.When the handle was extended, a portion of the needle did not exit the distal end of the catheter.It was estimated that the portion of the needle that detached from the device was approximately eight (8) mm.A discrepancy or anomaly that could have contributed to this observation was not found during our laboratory analysis of the returned product.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.Needle knife breakage near the distal end can occur if the product experiences limited movement of the needle knife during electrocautery application.The instructions for use state: "caution: it is essential to move cutting wire while applying current.Maintaining cutting wire in one position may cause excessive focal coagulation, charring of tissue and/or damage to cutting wire." maintaining the needle knife in one position can result in breakage of the needle knife.This is the most likely cause of needle breakage.Needle knife breakage near the distal end can also occur if the device is used with excessive cautery settings or if the needle makes contact with the distal end of the endoscope during a cautery application.The instructions for use direct the user: "before using this papillotome, follow the recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through the proper placement and utilization of the patient return electrode.Ensure a proper path from the patient return electrode to the electrosurgical unit is maintained throughout the procedure.When applying current, contact of cutting wire with endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to endoscope." prior to distribution, all fusion triple lumen needle knives are subjected to a visual inspection and functional test to ensure device integrity.A review of the device history record confirmed that this lot met manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence.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 (ercp), the physician used a cook fusion triple lumen needle knife.During the procedure, the device broke off and went into the patient.Additional information was provided by the cook district manager on 19-feb-2019: an additional device was used to complete the procedure.The additional information provided indicated that the section of the device was left in the patient.Clarification was received on 28-feb-2019 and indicated that the customer attempted to retrieve the broken portion but, that they were unsuccessful.The piece of the broken needle knife remained inside the patient¿s body to pass naturally.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 TRIPLE LUMEN NEEDLE KNIFE
• Type of Device: KNS, 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 Key: 8413831
• MDR Text Key: 142480647
• Report Number: 1037905-2019-00125
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002315396
• UDI-Public: (01)00827002315396(17)201107(10)W3992202
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2020
• Device Catalogue Number: FS-PRECUT
• Device Lot Number: W3992202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR