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.

• 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
• 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

• 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

• 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 Treatment Data

Date Received: 02/14/2022 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