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

Model Number A22255C

Device Problems Break (1069); Sparking (2595)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2022

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 295250914
• Report Number: 14308730
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 14042761036839
• UDI-Public: (01)14042761036839(11)200722(17)250327(10)1000062077
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 05/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic