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

Model Number	USG-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the evaluation, the manufacturer can not conclusively determine the cause of the reported complaint as the customer¿s accessories and hand pieces were not returned for analysis.The generator was returned and passed the output testing and functions as designed.Dents found on the touchscreen and rear chassis are due to customer's mishandling and do not affect the form, fit, or function of the device.A supplemental report will be submitted if additional information becomes available.The ultrasonic generator (usg-400) is intended to be used with the electrosurgical generator (esg-400), the thunderbeat transducer (td-tb400), the sonicbeat transducer (td-sb400), the thunderbeat, and / or the sonicbeat for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.The instructions for use state: "follow the dangers, warnings, and cautions described below when handling this ultrasonic generator.This information is supplemented by the dangers, warnings, and cautions described in each chapter.Use this equipment properly.If not properly used, it may cause deformation, breakage, patient and/or operator injury, malfunction of the cardiac pacemaker, burns of the surgeon, surgical staff and/or patient, electric shock, abnormal output or malfunction, perforation, bleeding, postoperative bleeding, tissue damage and infection to the surgeon, surgical staff and/or patient.".
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: 8922121
• Report Number: 8010047-2019-03005
• Device Sequence Number: 2396962
• Product Code: LFL
• UDI-Device Identifier: 04953170306747
• UDI-Public: 04953170306747
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K172691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 05/20/2019
• 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