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

Catalog Number HPC-3

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/12/2022

Event Type  malfunction  

Manufacturer Narrative

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.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 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 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 (ercp) procedure, the physician used a cook huibregtse triple lumen needle knife.It was reported that during pre-cutting, the tip of the papillotome detached and remained in the reference papilla.A section of the device did remain inside the patient¿s body.The tip of the papillotome detached and remained in the reference papilla.Prolongation of anesthesia was reported.Our attempts to collect additional information regarding if the piece of the device was left to pass naturally or if there was any intervention done to retrieve it have been unsuccessful.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.When tested as returned the remaining portion of the needle knife advanced with resistance to 2.5mm, then retracted fully.The distal portion of the remaining needle knife exhibits signs of use (blackening of the needle knife).According to the product drawing, the needle is specified to extend from the catheter with the stopper block set flush at the 7th mark on the handle stem.With the stopper block set to the 7th mark, the remaining segment of the needle knife was not long enough to exit the catheter.We are unable to determine the exact length of the detached portion.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: our evaluation of the returned device confirmed the report of needle knife breakage.A definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation (detached needle portion not returned).A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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.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 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 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: HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE
• 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: 15562089
• MDR Text Key: 306077880
• Report Number: 1037905-2022-00554
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 10827002248851
• UDI-Public: (01)10827002248851(17)250524(10)W4599278
• 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,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HPC-3
• Device Lot Number: W4599278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• 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: ERBE ELECTROSURGICAL GENERATOR; OLYMPUS TJF-Q190V ENDOSCOPE