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

Model Number	UES-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that a patient complained of pain 5 to 7 days after a trans-urethral resection of the prostate (turp) using the subject device.The user facility diagnosed the patient and found the urethra rupture and the urethral burns.It was reported that there was no malfunction on the subject device.There was no further detailed information reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct the event description.Omsc has submitted two reports, mfr report #8010047-2020-01765 and 8010047-2020-01766, for 2 patients involvement in the event.Additional information confirmed that only one patient was involved in the event.This report remains valid and the other report #8010047-2020-01765 is invalid.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The device was not returned to olympus medical systems corp.(omsc), but returned to olympus repair center for the evaluation.According to the evaluation, olympus repair center could not confirm the malfunction of the device.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.If significant additional information is received, this report will be supplemented.

• 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: 9822214
• Report Number: 8010047-2020-01766
• Device Sequence Number: 1213260
• Product Code: GEI
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2021

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: Health Professional
• Device Model Number: UES-40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 01/20/2021
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 10/30/2020; 02/14/2021
• 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: Other; Required Intervention