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

Model Number 7 FR

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Abscess (1690)

Event Date 11/20/2019

Event Type  Injury  

Event Description

Bugby ball tip came off electrode while in pt prostatic abscess.Part was retrieved.Fda safety report id# (b)(4).

• Brand Name: GREENWALD SURGICAL CO BALL TIP FLEXIBLE ELECTRODE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE UROLOGICAL
• Manufacturer (Section D): GREENWALD SURGICAL CO., INC.
• MDR Report Key: 9376716
• MDR Text Key: 168181875
• Report Number: MW5091294
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2019

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
• Device Model Number: 7 FR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR