MAUDE Adverse Event Report: GRACE MANUFACTURING / GREENWALD SURGICAL GREENWALD SURGICAL; MONOPOLAR CORD M25 77000-01

Model Number	77000-01
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned to manufacturer for evaluation.No investigation can be completed.
Event or Problem Description
From our customer: "during a cystoscopy with bladder biopsy procedure, the md noted that the bugbee electrode was not functioning when activated.The rn checked the cord and while trying to troubleshoot, the end of the cord became disconnected and the rn noted that the cord had a slight "burned" smell to it.A new cord was opened to the surgical field and the case was completed without further incident.At no point did anyone see any smoke or fire, the rn just noted an odd smell when he sniffed the cord.Reported to fda - (b)(4)".

• Brand Name: GREENWALD SURGICAL
• Common Device Name: MONOPOLAR CORD M25 77000-01
• Manufacturer (Section D): GRACE MANUFACTURING / GREENWALD SURGICAL; 614 sr 247; russellville AR 72802
• Manufacturer (Section G): GRACE MANUFACTURING; 614 sr 247; russellville AR 72802
• Manufacturer Contact: shanyce hixson ; 614 sr 247; russellville, AR 72802
• MDR Report Key: 21069421
• Report Number: 1818662-2025-00001
• Device Sequence Number: 8484276
• Product Code: FBJ
• UDI-Device Identifier: 10801334001278
• UDI-Public: 10801334001278
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 77000-01
• Device Catalogue Number: M25
• Device Lot Number: 103636-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown