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

Model Number	UES-40
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report is not being returned to olympus.It will be evaluated in the field by an olympus field service engineer.The definitive cause of the user's experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
The customer reports during a transurethral resection in saline (turis) procedure using an electrical surgical unit with a foot pedal, after about an hour of use, the physician released the foot pedal, but the device did not disengage resulting in a hole in the patient¿s bladder.The operation was abandoned, and the patient was sent to recovery.The surgeon is a regular user of the equipment and does not believe this was caused by to user error.The next scheduled maintenance for the device was due (b)(6).The device has worked fine on prior procedures.The customer has requested a field service coordinator to come in and inspect the equipment.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.Case with patient identifier (b)(6) reports the electrosurgical unit used in the procedure.Case with patient identifier (b)(6) reports the foot pedal used in the procedure.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.The device referenced in this report was not returned to olympus for evaluation.The investigation findings are based on informamtion provided by the customer.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.Conclusion: the definitive cause of the reported events could not be established.

• 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: 14428205
• Report Number: 8010047-2022-08382
• Device Sequence Number: 17758672
• Product Code: GEI
• UDI-Device Identifier: 04953170287275
• UDI-Public: 04953170287275
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2010
• 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; Hospitalization
• Patient Sex: Unknown