MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP.; ULTRASONIC SURGICAL DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Blood Loss (2597)

Event Type  Death  

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 at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

On march 31, 2020, olympus medical systems corp.(omsc) received literature titled ¿20 years' experience with laparoscopic splenectomy.Single center outcomes of a cohort study of 500 cases¿.In the literature, it was reported that one patient died.The patient was reoperated two times after laparoscopic splenectomy because of massive bleeding.The bleeding was finally stopped but after the second operation the patient died.The literature indicated that the subject device "thunderbeat" and the competitor's device "ligasure" were used for the closure of the vascular branches in the splenic hilum during the laparoscopic splenectomy.It was reported that the subject device was thunderbeat, but no information was provided about the model name.The literature did not indicate which device was used for the event and the exact cause of the event.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.

• Type of Device: ULTRASONIC SURGICAL DEVICE
• 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 Key: 9984456
• MDR Text Key: 188523300
• Report Number: 8010047-2020-02302
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K111202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death