MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC HUIBREGTSE NEEDLE KNIFE PAPILLOTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number HPC-2

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion triple lumen needle knife.It was reported that the cutting wire of the needle knife detached during operation.A section of the device did remain inside the patient¿s body and it was retrieved with a grasping device.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.

Manufacturer Narrative

Pma/510(k) # k040981.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.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.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.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the handle/needle in a slightly retracted position.A visual examination of the distal end confirmed that less than 2 mm of the needle was still attached to the device, with the rest of the needle not being returned.It is unknown how a portion of the needle detached from the device.The needle is specified to extend 4mm -/- 1mm so it is estimated that more than 2 mm of the needle detached from the device or disintegrated.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 evaluation of the returned device confirmed a portion of the needle was missing from the device.The additional information received indicated that the user held the needle knife stationary.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 needle knife while applying current." 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 device, follow recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode.Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure." the instructions for use caution the user: "when applying current, ensure needle knife is completely out of endoscope.Contact of needle knife with endoscope may cause grounding, which can result in patient injury, operator injury, a broken needle knife, and/or damage to endoscope." prior to distribution, all huibregtse needle knife papillotomes are subjected to a visual inspection and functional test to ensure device integrity.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 comments regarding this report: based on the information provided that the user held the needle stationary when current was applied.A cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook huibregtse needle knife papillotome.It was reported that the cutting wire of the needle knife detached during operation.A section of the device did remain inside the patient¿s body and it was retrieved with a grasping device.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: HUIBREGTSE NEEDLE KNIFE PAPILLOTOME
• Type of Device: 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: 15059732
• MDR Text Key: 304719193
• Report Number: 1037905-2022-00404
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 10827002220376
• UDI-Public: (01)10827002220376(17)240323(10)W4452000
• Combination Product (y/n): N
• PMA/PMN Number: K972674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Catalogue Number: HPC-2
• Device Lot Number: W4243530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2019
• 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
• Treatment: GRASPING DEVICE, MAKE AND MODEL UNKNOWN; OLYMPUS DUODENOSCOPE, MODEL UNKNOWN