MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number KD-V411M-0725

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

Patient Problems Inflammation (1932); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

Average age/years for patients 72 (42-88).Gender: male ((b)(6)) and female ((b)(6)).The suspect device has not been returned to olympus for evaluation and the investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus received the following literature article: endoscopic ultrasonography-guided fine needle aspiration for extrahepatic cholangiocarcinoma: a safe tissue sampling modality by t.Onoyama, et al.The study evaluated the efficacy and safety of endoscopic ultrasonography-guided fine needle aspiration (eus-fna) for diagnosing extrahepatic cholangiocarcinoma (ecc) compared with endoscopic retrograde cholangiopancreatography (ercp) tissue sampling.Patients who underwent eus-fna or ercp tissue sampling to differentiate ecc from benign biliary disease were enrolled retrospectively between october 2011 and march 2017.The diagnostic performances of eus-fna and ercp tissue sampling based on pathological evaluation.The study compared adverse events in eus-fna and ercp tissue sampling.Seventy-three (73) patients with biliary disease were enrolled.Eus-fna and ercp were performed in 19 and 54 patients, respectively.Sensitivity, specificity, and accuracy of ercp tissue sampling were 76.0%, 100%, and 88.9%, respectively, and for eus-fna these were 81.8%, 87.5%, and 84.2%, respectively.Statistical values of ercp tissue sampling and eus-fna were not significantly different.The adverse event frequency of eus-fna was significantly lower than that of ercp tissue sampling (0% vs.25.9%, p = 0.033).The diagnostic ability of eus-fna for ecc is similar to that of ercp tissue sampling.Eus-fna is a safer tissue sampling modality than ercp for the evaluation of extrahepatic biliary disease.Complications occurred in the ercp group such as acute pancreatitis occurred at a rate of 14.8% (8/54), with one case of severe pancreatitis.Infection occurred at a rate of 11.1% (6/54, cholangitis).All cases were resolved with conservative treatment.Serious adverse events such as perforation or hemorrhage were not observed.There was no procedure-related mortality.In conclusion, the study demonstrated that the diagnostic ability of eus-fna for ecc is similar to that of ercp tissue sampling.Eus-fna is a safer tissue sampling modality than ercp for the evaluation of extrahepatic biliary disease.The single use 3-lumen sphincterotome v kd-v411m-0725 was used in ercp procedures which required an endoscopic sphincterotomy for difficult cases.The adverse events reported in the study: ercp: acute pancreatitis (7).Severe pancreatitis (1).Infection (cholangitis) (6).This event includes three (3) reports: (b)(6) for jf-260v (b)(6) for fb-45q-1 (b)(6) for kd-v411m-0725 this is report 3 of 3 for (b)(6) for kd-v411m-0725.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: SINGLE USE 2-LUMEN SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13528633
• MDR Text Key: 290372565
• Report Number: 8010047-2022-02930
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170184031
• UDI-Public: 04953170184031
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0725
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2022
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: FB-45Q-1 BIOPSY FORCEPS; G-260-2545A - SINGLE USE GUIDEWIRE; JF-260V - EVIS LUCERA DUODENOVIDEOSCOPE; M00535700 ¿ CANNULA, BOSTON SCIENTIFIC CORPORATION; M00556051-0.035-IN GUIDEWIRE, BOSTON SCIENTIFIC
• Patient Outcome(s): Other