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

Catalog Number HPC-3

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 08/06/2015

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook huibregtse triple lumen needle knife to perform a sphincterotomy.The needle was held stationary while applying current.Before they started to cut, they saw that the tip of the needle knife was broken.The initial reporter stated that an approximately 2 mm section of the device remained inside the patient's body and was not retrieved due to visibility.They used another huibregtse triple lumen needle knife to complete the procedure.

Manufacturer Narrative

On 9/8/2015, we became aware that the information provided in the other remarks section was not submitted on the initial emdr.Investigation evaluation: our evaluation confirmed detachment of a portion of the needle knife.The needle knife was extended from the distal end of the catheter to the distance allowed by the handle for full needle knife extension.A visual examination of the distal tip of the device confirmed the tip of the needle was blackend and damaged from cautery application.Also noted, the handle stem is broken.The device was inspected according to manufacturer specifications.This inspection confirmed that a portion of the needle knife was missing.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: 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 device is used with excessive cautery settings.The instructions for use direct the user to verify the desired settings by following the electrosurgical unit manufacturer¿s instructions.Needle knife breakage near the distal end can occur if the needle makes contact with the distal end of the endoscope during a cautery application.The instructions for use for this product line caution that the needle knife must fully exit the endoscope when applying current.Needle knife breakage near the distal end can also occur if the product experiences limited movement of the needle knife during electrocautery application.The instructions state that it is essential to move the needle knife while applying current.Maintaining the needle knife in one position can result in breakage of the needle knife.Breakage of the handle stem can occur if the device experiences excessive pressure during use and/or general handling.The instructions for use for this product advise the user to advance the device through the accessory channel in short increments.This activity will aid in device preservation.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.Additional comments regarding this report: based on the information provided, 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.

• Brand Name: HUIBREGTSE 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 Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 5039335
• MDR Text Key: 24440849
• Report Number: 1037905-2015-00375
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K972674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HPC-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/06/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• 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: 66 YR
• Patient Weight: 81