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

Model Number	UES-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional 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 4 of 5.
Event or Problem 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
• Common Device Name: ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 6921508
• Report Number: 8010047-2017-10114
• Device Sequence Number: 10975843
• Product Code: KNS
• UDI-Device Identifier: 04953170287275
• UDI-Public: 04953170287275
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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: Other Health Care Professional
• Device Model Number: UES-40
• 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: 09/09/2017
• Initial Report FDA Received Date: 10/06/2017
• 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; Other