MAUDE Adverse Event Report: OLYMPUS WINTER IBE GMBH OLYMPUS; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	WA22606S
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The bipolar set was broken such that visualization was so bad it was unsafe to continue with the surgery.Vision was ok at the beginning of the case but as soon as there was some bleeding, visualization deteriorated.

• Brand Name: OLYMPUS
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER IBE GMBH; 800 west park drive; westborough MA 01581
• MDR Report Key: 20256068
• Report Number: 20256068
• Device Sequence Number: 20804885
• Product Code: FAS
• UDI-Device Identifier: 14042761085158
• UDI-Public: (01)14042761085158
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/12/2024
• Report Date (Section F): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: WA22606S
• Device Catalogue Number: WA22606S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Date Report Sent to FDA: 06/12/2024