MAUDE Adverse Event Report: OLYMPUS WINTER IBE GMBH OLYMPUS; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	A22255C
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Shortly after the procedure is started, a loud pop is heard and immediately realized that monopolar cord sparked and broken off where it attaches to esu (electro-surgical unit) machine.

• Brand Name: OLYMPUS
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): OLYMPUS WINTER IBE GMBH; 800 west park drive; westborough MA 01581
• MDR Report Key: 14308730
• Report Number: 14308730
• Device Sequence Number: 14664261
• Product Code: KNS
• UDI-Device Identifier: 14042761036839
• UDI-Public: (01)14042761036839(11)200722(17)250327(10)1000062077
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/01/2022
• Report Date (Section F): 05/01/2022

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
• Operator of Device: Other
• Device Model Number: A22255C
• Device Catalogue Number: A22255C
• Device Lot Number: 1000062077
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2022
• 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 Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 05/01/2022