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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GENERATOR
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OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GENERATOR Back to Search Results
Model Number USG-400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn, Thermal (2530); Abdominal Distention (2601)
Event Date 07/17/2019
Event Type  Injury  
Event Description
It was reported that the patient experienced a burn injury during a diagnostic laparoscopic procedure for an ectopic pregnancy while using a usg-400 generator.A week later the patient was experiencing bloating.The patient was re-scoped on (b)(6) 2019 and the physician found burned tissue in the patient.The patient underwent an exploratory laparotomy and the surgeon removed the patient's appendix and cecum.There was no further patient injury or harm reported after this procedure.
 
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Brand Name
ULTRASONIC GENERATOR
Type of Device
ULTRASONIC GENERATOR
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key8928948
MDR Text Key155468650
Report Number2951238-2019-01067
Device Sequence Number1
Product Code LFL
UDI-Device Identifier04953170306747
UDI-Public04953170306747
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 08/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUSG-400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/25/2019
Distributor Facility Aware Date07/25/2019
Event Location Hospital
Date Report to Manufacturer07/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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