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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Flatus (1865); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Perforation (2001); Fluid Discharge (2686); Gastrointestinal Hemorrhage (4476); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 01/01/2008

Event Type  Injury  

Event Description

Cook became aware of the following events involving cook huibregtse needle knife papillotomes from a post market clinical follow up study report.The events were reported as follows: hemorrhage: 2 patients - required repeat endoscopic procedure to successfully control the bleeding.Hemorrhage: 3 patients - post procedure to 30 days - intervention is likely.Perforation: 2 patients - no information about intervention.Post-ercp pancreatitis: 9 patients - no information about intervention.Infection: 2 patients - no information about intervention.Bile leak: 1 patient - no information about intervention.Episode of a.Fib [cardiac arrhythmia]: 1 patient - no information about intervention pneumobilia: 2 patients - no information about intervention.It was not reported if a section of the device remained inside the patient's body.Two (2) patients required repeat endoscopic procedure to successfully control the bleeding.Three (3) patients experienced post procedure to 30 days bleeding, but no information was provided on how it was treated.No intervention information was provided for the remaining patients.No further information was provided in the study report.

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.

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.A review of the device history record could not be conducted because the 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.However, a device failure was not reported in the article.The article reported occurrences of bleeding, perforation, pancreatitis, and infection.All are known complication of these types of procedures.The instructions for use include the following potential complications: "potential adverse events associated with papillotomy include but are not limited to: pancreatitis, bleeding, perforation, and infection." prior to distribution, all huibregtse needle knife papillotomes are subjected to a visual inspection and functional test to ensure device integrity.Corrective action: 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 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: 15159766
• MDR Text Key: 297210029
• Report Number: 1037905-2022-00447
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ENDOSCOPE, UNKNOWN MAKE OR MODEL.
• Patient Outcome(s): Required Intervention