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

Catalog Number HPC-2

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); Perforation of Esophagus (2399)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Manfredi, m., et al.(2018).Endoscopic electrocautery incisional therapy as a treatment for refractory benign pediatric esophageal strictures.European society for pediatric gastroenterology, hepatology, and nutrition and north american society for pediatric gastroenterology, hepatology, and nutrition, jpgn, volume 67, number 4, p.464-468.Doi: 10.1097/mpg.0000000000002008.Date range of the information contained in the article: may 2011-september 2017.Concomitant medical products: erbe icc200 electrosurgical generator, erbe vio 330d electrosurgical generator.This investigation is on-going.Once complete, a follow-up emdr report will be provided.

Event Description

Cook endoscopy was notified of four (4) events that occurred with the cook huibregtse needle knife papillotome.Please see below for relevant excerpts of this article."refractory esophageal strictures are rare conditions in pediatrics, and are often due to anastomotic, congenital, or caustic strictures.Although not as widely used, endoscopic electrocautery incisional therapy (eit) [abnormal use of cook huibregtse needle knife papillotome] has been reported as an alternative treatment for refractory strictures in a small number of adult series.The aim of the study was to evaluate the safety and efficacy of eit in a pediatric population with refractory esophageal strictures.Our eit technique involves the use of a needle knife to make incisions into a stricture at its most dense points.We use the huibregtse needle knife papillotome (cook medical, winston-salem, nc) to perform eit.There were.4 maes [minor adverse events].All minor events were small contained leaks [fluid did not leak from the pleural space] that required no intervention; patients were discharged home within 24 hours of the procedure." it was not published in the article if a section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.It is unknown if the patient experienced any adverse effects due to this occurrence, but no adverse effects were reported in the published case report.

Manufacturer Narrative

Manfredi, m., et al.(2018).Endoscopic electrocautery incisional therapy as a treatment for refractory benign pediatric esophageal strictures.European society for pediatric gastroenterology, hepatology, and nutrition and north american society for pediatric gastroenterology, hepatology, and nutrition, jpgn, volume 67, number 4, p.464-468.Doi: 10.1097/mpg.0000000000002008.Date range of the information contained in the article: may 2011-september 2017 continued from section d.11: erbe icc200 electrosurgical generator.Erbe vio 330d electrosurgical generator.Investigation evaluation: an evaluation of the photos included in the literature article confirmed the area the device was used.We were unable to visualize the device properly in the photos and hence could not confirm the report.Without return of the complaint device a complete evaluation could not be performed.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: the user indicated that endoscopic electrocautery incisional therapy (eit) was performed using the needle knife to treat refractory esophageal strictures.This is outside the intended use of the device.The huibregtse needle knife papillotome is intended to be used in the common bile duct.The instructions for use advise the user: "this device is used for accessing the common bile duct when standard methods of cannulation have been exhausted and or papillotomy.This device is supplied sterile and is intended for single use only." use of the device outside the intended use is the most likely cause for the reported observation.Prior to distribution, all huibregtse needle knife papillotomes are subjected to a visual inspection and functional test to ensure device integrity.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 this device was used off-label, 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

Cook endoscopy was notified of four (4) events that occurred with the cook huibregtse needle knife papillotome.Please see below for relevant excerpts of this article."refractory esophageal strictures are rare conditions in pediatrics, and are often due to anastomotic, congenital, or caustic strictures.Although not as widely used, endoscopic electrocautery incisional therapy (eit) [abnormal use of cook huibregtse needle knife papillotome] has been reported as an alternative treatment for refractory strictures in a small number of adult series.The aim of the study was to evaluate the safety and efficacy of eit in a pediatric population with refractory esophageal strictures.Our eit technique involves the use of a needle knife to make incisions into a stricture at its most dense points.We use the huibregtse needle knife papillotome (cook medical, winston-salem, nc) to perform eit.There were.4 maes [minor adverse events].All minor events were small contained leaks [fluid did not leak from the pleural space] that required no intervention; patients were discharged home within 24 hours of the procedure." it was not published in the article if a section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.It is unknown if the patient experienced any adverse effects due to this occurrence, but no adverse effects were reported in the published case report.

• Brand Name: HUIBREGTSE NEEDLE KNIFE PAPILLOTOME
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8903799
• MDR Text Key: 155989114
• Report Number: 1037905-2019-00472
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HPC-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PEDIATRIC ENDOSCOPE, UNKNOWN MAKE OR MODEL
• Patient Outcome(s): Other