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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 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number KD-V411M-0725
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Peritonitis (2252); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)
Event Type  Injury  
Event Description
Olympus reviewed the following literature: permanent endoscopic gallbladder stenting versus removal of gallbladder drainage,long-term outcomes after management of acute cholecystitis in high-risk surgical patients for cholecystectomy:multi-center retrospective cohort study" by a. Maruta, t. Iwashita, and keisuke iwata et al.     endoscopic transpapillary gallbladder drainage (egbd) has been reported as an effective gallbladder drainage treatment option for acute cholecystitis in high-risk surgical patients. However, the long-term outcomes such as cholecystitis' recurrence rate after placement of egb stenting (egbs) have not been well studied yet. The authors used 3 olympus devices and did not specify the adverse events in relation to the devices and therefore, the adverse events will be reported for all olympus devices (b)(6): kd-v411m-0725. (b)(6): kd-211q-0725. Complaint 3 visiglide2. 1 - pancreatitis. 1 - cystic duct injury, managed conservatively. 3 - bile peritonitis, managed conservatively. Late adverse events (6 months and 1 year). 22 - cholecystitis reoccurrence. 11 -common bile duct stones. 3 - common bile duct stones and reoccurrence of cholecystitis. This is report 1 of 3 for (b)(6): kd-v411m-0725.
 
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation. The investigation is in process. The literature article is attached for additional information. Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
 
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Brand NameSINGLE USE 3-LUMEN SPHINCTEROTOME V
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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 Key13603579
MDR Text Key290770232
Report Number8010047-2022-03598
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 05/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
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 Received04/07/2022
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 Treatment Data
Date Received: 02/25/2022 Patient Sequence Number: 1
Treatment
VISIGLIDE2
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