MAUDE Adverse Event Report: GREENWALD SURGICAL CO., INC. BUGBEE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/29/2022

Event Type  malfunction  

Event Description

Green olympus bugbee electrode broke apart inside the patient, and the round ball was loose in patient.All pieces of the bugbee electrode were obtained and out of the patient's body before closure.A bugbee is a long polar electrode for cautery usually used in urology cases.There is a silver ball that is part of the system and came loose in patient.There is not packaging for bugbee as it comes in the cysto minor tray.

• Brand Name: BUGBEE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GREENWALD SURGICAL CO., INC.; 614 sr 247; russellville AR 72802
• MDR Report Key: 15592558
• MDR Text Key: 301644684
• Report Number: 15592558
• Device Sequence Number: 1
• Product Code: FAS
• 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: 09/19/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male