MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC UNKNOWN; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 01/01/2006

Event Type  Death  

Event Description

The following was published in a clinical literature article involving cook papillotomes: "data of 413 patients who underwent therapeutic ercp from january 1994 to december 2004 were reviewed.Among these patients, 63 were 90 years of age or older (group a) and 350 were between 70 and 89 years (group b).Hospital location not reported- data collected from facilities in thessaloniki, greece.Sphincterotomies and pre-cut papillotomies were performed by using.Cook endoscopy instruments (papillotomes, wilson cook medical inc, winston-salem, nc).Post sphincterotomy bleeding and death was reported." it was not published in the article if a section of the device remained inside the patient's body.It was published in the article that the patient experienced post sphincterotomy bleeding and death.

Manufacturer Narrative

Katsinelos, 2006.Doi:10.1016/j.Gie.2005.09.051.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.Bleeding is a 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 cook endoscopy papillotomes/needle knives 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.

• Brand Name: UNKNOWN
• 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: 15056007
• MDR Text Key: 296171155
• Report Number: 1037905-2022-00400
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• 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: OLYMPUS ENDOSCOPE, UNKNOWN MODEL
• Patient Outcome(s): Death