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

Catalog Number FS-PRECUT

Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

Patient Problem Injury (2348)

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant: erbe electrosurgical generator.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 could not be reviewed because a lot number was not provided.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.Instructions for use state: "uncoil papillotome and carefully remove precurved stylet wire from distal tip of device.Note: do not extend or retract cutting wire while device is coiled or stylet wire is in place, as this may cause damage to papillotome and render it inoperable.Extend and retract cutting wire only when papillotome is straight and stylet is removed".Instructions for use state: "position catheter and extend cutting wire to desired length.Note: cutting wire extension may be adjusted by loosening thumbscrew and advancing or retracting adjustable ring on handle.Caution: it is essential to tighten thumbscrew after adjusting cutting wire length and before proceeding with papillotomy." prior to distribution, all fusion triple lumen needle knives are subjected to a visual examination and functional test to ensure device integrity.During testing the handle is manipulated ensuring the cutting wire extends and retracts.The length of the cutting wire is also measured referencing the drawing.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 a papillotomy, the physician used a cook fusion triple lumen needle knife.As reported to the district manager, "the physician had a problem with a cook needle knife.They adjusted the length the needle length and locked it in place.He did the papillotomy and noticed when he withdrew the needle knife that the needle had advanced out more, even though it was still locked.He put a stent in the patient as he was not sure how deep the cut was.".

• 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 Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7188999
• MDR Text Key: 97311075
• Report Number: 1037905-2018-00019
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K040981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FS-PRECUT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2017
• Event Location: Hospital
• Date Manufacturer Received: 12/21/2017
• 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 Outcome(s): Required Intervention