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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME Back to Search Results
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.
 
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Brand NameSINGLE USE 3-LUMEN SPHINCTEROTOME V
Type of DeviceSINGLE 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 Key13528633
MDR Text Key290372565
Report Number8010047-2022-02930
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K950166
Number of Events Reported1
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 Received02/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-V411M-0725
Device Lot NumberUNKNOWN(LITERATURE)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/31/2022
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
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