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

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

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 patitne.There is not packaging for bugbee as it comes in the cysto minor tray.Original intended procedure: cysto bladder biopsy with fulgeration.

Manufacturer Narrative

Hospital listed device as "bugbee electrode" and failed to provide a part number, udi number, size, model number, or serial number.The device was returned to the olympus (our customer).Greenwald surgical has not recieved the device to evaluate.

• Brand Name: BUGBEE
• Type of Device: ELECTRODE, ELETROSURGICAL, ACTIVE
• Manufacturer (Section D): GREENWALD SURGICAL CO., INC.; 614 sr 247; russellville AR 72802
• Manufacturer (Section G): GREENWALD SURGICAL; 614 sr 247; russellville AR 72802
• Manufacturer Contact: shanyce day ; 614 sr 247; russellville, AR 72802
• MDR Report Key: 15710311
• MDR Text Key: 307670778
• Report Number: 1818662-2022-00001
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• 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?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male