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

Model Number	SONOSURG-G2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.
Event or Problem Description
On (b)(6) 2021, olympus medical systems corp.(omsc) received the literature titled "predictive model for postoperative pleural effusion after hepatectomy".This study was conducted on the hepatectomy for 325 patients.In the literature, it was reported as follows; this study aims to develop a predictive model for severe postoperative pleural effusion after hepatectomy.The consecutive patients underwent hepatectomy between (b)(6) 2013 and (b)(6) 2020.Of the patients, 204 underwent laparotomies and 121 underwent laparoscopic hepatic resections.All patients were diagnosed with 174 hepatocellular carcinomas (hcc), 82 colorectal liver metastases (crlm), 44 of biliary cancer, and 25 of others.Hepatic parenchymal transection was performed with the subject device (cavitron ultrasonic surgical aspirator (cusa)) or clamp crush technique.The complications (clavien-dindo 3 or more) were 59 patients.The complications included 22 severe postoperative pleural effusion (spope), 28 bile leakage, 2 operative death.And, 27 transfusions needed intraoperative blood loss was reported.Omsc assumes that spopes were not identified as a relationship with the subject device because there is no indication in the literature.Omsc assumes that bile leakage was not identified as a serious adverse event because there is no indication in the literature.Whereas, omsc assumes that the transfusion needed intraoperative blood loss was a serious adverse event that causes or contributes to a death or serious injury due to hepatic parenchymal transection was performed with the subject device.Omsc assumes that the operative death was related to the subject device due to hepatic parenchymal transection was performed with the subject device.Based on the available information, specific information on the subject device was not provided.There is no description of the device's malfunction.Omsc will submit two medical device reports (mdr) for the operative death and the transfusion needed intraoperative blood loss.This report is 2of 2.This report is about the serious adverse event of 27 transfusion needed intraoperative blood losses that might be caused or contributed to a death or serious injury.

• Brand Name: SONOSURG GENERATOR
• Common Device Name: GENERATOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12126126
• Report Number: 8010047-2021-08506
• Device Sequence Number: 14560195
• Product Code: LFL
• UDI-Device Identifier: 04953170319624
• UDI-Public: 04953170319624
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: No Information
• Device Model Number: SONOSURG-G2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 07/07/2021
• 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: Required Intervention