MAUDE Adverse Event Report: COOK ENDOSCOPY DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number PTG-20-6-BII-NG

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

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Patient information: age: 71.18 +/-10.39 years.Gender: males 58 (77.3); females 17 (22.7).Pma/510(k) #: k172665.Citation: caglar, e., atasoy, d., tozlu, m., altinkaya, e., dogan, s., & senturk, h.(2020).Experience of the endoscopists matters in endoscopic retrograde cholangiopancreatography in billroth ii gastrectomy patients.Clinical endoscopy, 53(1), 82¿89.Https://doi.Org/10.5946/ce.2019.073.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.It is unknown at what times, during or after the procedures, the adverse effects experienced occurred.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 double lumen wire guided billroth ii sphincterotomes 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.

Event Description

Cook endoscopy was notified of this event via a clinical literature article.The article was published in 2019.Included are relevant excerpts from the article to capture the three (3) cases of bleeding in procedures where the cook double lumen wire guided billroth ii sphincterotome was used.The authors of the study ¿aimed to investigate the safety and efficacy of performing ercp [endoscopic retrograde cholangiopancreatography] with a side-viewing endoscope in patients who had undergone a billroth ii operation and to assess the role of endoscopist experience.Data of patients who underwent billroth ii gastrectomy for whom ercp was performed between 2014 and 2018 in two endoscopy centers were retrieved.The upper gastrointestinal tract was first assessed with a front-viewing endoscope.Ercp procedures were performed under fluoroscopy.In case of failure, precut sphincterotomy (fusion; cook medical, winston-salem, nc, usa), an antegrade technique (n=1 patient), and a double guidewire technique were used.In patients with failure in the first attempt with the duodenoscope, a second attempt was performed with a gastroscope or pediatric colonoscope 3¿5 days later.Sphincterotomy was performed with an inverted sphincterotome (billroth ii sphincterotome; cook medical) [subject of report] or insulated-type/ordinary needle knife after inserting a 5-f stent in the pancreatic duct, if not possible in the common bile duct, and cutting from the roof toward the stent.Results.None of the patients treated by the inexperienced endoscopist had.Bleeding.Whereas among those treated by the experienced endoscopist.5% (3/59) had bleeding.Bleeding was detected in 3 patients [subject of this report].Precut sphincterotomy was performed in all patients.All the patients with bleeding underwent precut sphincterotomy.Bleeding complication rates were reported to increase after precut in patients who had undergone billroth ii gastrectomy.Conservative management was successful in all the 3 cases.¿ it was not reported if a section of the device remained inside the patient¿s body.The three patients who experienced bleeding were successfully managed conservatively.According to the initial reporter, the patients experienced bleeding following precut sphincterotomy.

• Brand Name: DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME
• 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 (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: 12193691
• MDR Text Key: 265827993
• Report Number: 1037905-2021-00331
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PTG-20-6-BII-NG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR