MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GENERATOR

Model Number	USG-400
Health Effect - Clinical Codes	Burn, Thermal (2530); Abdominal Distention (2601)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.

• Brand Name: ULTRASONIC GENERATOR
• Common Device Name: ULTRASONIC GENERATOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8928948
• Report Number: 2951238-2019-01067
• Device Sequence Number: 14004756
• Product Code: LFL
• UDI-Device Identifier: 04953170306747
• UDI-Public: 04953170306747
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2019
• Report Date (Section F): 08/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: USG-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Date Report Sent to FDA: 08/25/2019