MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ELECTROSURGICAL UNIT

Model Number UES-40

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

The referenced ues-40 is not return to olympus medical systems corp.(omsc) for evaluation, therefore omsc cannot evaluate the ues-40 yet.Therefore the exact cause of the reported event could not be conclusively determined at this time.However, according to the literature, postoperative bleeding is known as common complication of tur-p procedure.Furthermore, it was aware that the facility reused the disposable electrode.The reported phenomenon is thought of as common complication of tur-p procedure with incorrect usage of the device.The ues-40 instruction manual states the notice for bleeding and appropriately handling of the device.There were no further details provided.If significant additional information is received, this report will be supplemented.This report is 5 of 5.

Event Description

A couple of days after the turis-p procedure, the bleeding were observed through the drainage catheter for five patients.The physician performed the irrigation of the bladder.The patients were prolonged the hospitalization.

• Brand Name: ELECTROSURGICAL UNIT
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507
• MDR Report Key: 6921435
• MDR Text Key: 88922816
• Report Number: 8010047-2017-10115
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170287275
• UDI-Public: 04953170287275
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K030194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: UES-40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other