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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-0320
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolism/Embolus (4438)
Event Type  Injury  
Event Description
Olympus reviewed the following literature article: "a rare but lethal complication: post-endoscopic retrograde cholangiopancreatography cerebral arterial gas embolism" by hin san chow et al.   iatrogenic air embolism is a rare and potentially fatal complication of gastrointestinal endoscopy. The study presented a (b)(6) male patient who developed cerebral arterial gas embolism shortly after therapeutic endoscopic retrograde cholangiopancreatography (ercp) for acute biliary pancreatitis, which is the first case reported in (b)(6) according to latest literature search. Some risk factors of iatrogenic air embolism in this patient include cholangitis with intraductal stones, sphincterotomy and bleeding at papillotomy site which required haemostasis with balloon tamponade. Early diagnosis and timely treatment with hyperbaric oxygen therapy resulted in full neurological recovery of the patient.   type of adverse events/number of patients post-endoscopic retrograde cholangiopancreatography cerebral arterial gas embolism - (1)  .
 
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 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 Key14192726
MDR Text Key294645394
Report Number8010047-2022-06975
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-V411M-0320
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 Received03/27/2022
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: 04/25/2022 Patient Sequence Number: 1
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