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

Model Number	UES-40
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported during an unspecified bladder procedure using a ues-40 electrosurgical unit, the patient experienced a bladder perforation.The surgeon requested to use bipolar diathermy during the procedure, someone else suggested monopolar.The surgeon started at 100, the lower setting, but not much happened, the power was increased to 150 then 200 eventually, the surgeon went a little deeper and perforated the bladder.Additional details regarding the patient and reported event have been requested.At this time, no further information has been provided.
Additional Manufacturer Narrative
The device referenced in this report has not been sent to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Additional Manufacturer Narrative
The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following warnings related to the reported event: danger the maximum output voltage characteristics of the ues-40 are shown below.When setting the output level, first set it to a low level and increase it gradually.If the output is initially set to a high level, the electrode¿s insulation may be damaged and cause operator and/or patient burns.Furthermore, it is recommended that you perform basic experiments before using the ues-40.If the instruction manual for the endoscopic accessory to be used stipulates a rated voltage, the output should be set so that it does not exceed that voltage.Conclusion: the definitive cause of the reported events could not be established.From the investigation findings, we could not obtain confirmation regarding defects or failures in the product in question when requested.There were no reports of device malfunction.Due to these factors, it is unlikely the reported event is due to a product malfunction.When using the "saline" (i.E., bipolar) treatment modes, the recommended settings are 280-320 w at cutting and 90-100w and to always use the appropriate lowest output level in order to obtain the effect of the purpose (that is, when setting the output level, it was first set to the low level and then gradually raised) when executing coagulation with ues-40 electrosurgery generator.These are provided to the customer as a safety guideline.Olympus cannot comment on the technique of surgeons from the content of the instructions for use.Each surgeon makes clinical decision/action based on the individual situation.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12786484
• Report Number: 8010047-2021-14397
• Device Sequence Number: 4081286
• Product Code: GEI
• UDI-Device Identifier: 04953170165429
• UDI-Public: 04953170165429
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: UES-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown