MAUDE Adverse Event Report: GRACE MANUFACTURING, INC. GREENWALD SURGICAL COMPANY, INC.; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number 25821-06

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2020

Event Type  malfunction  

Event Description

The tip of the catheter broke off during the procedure.

• Brand Name: GREENWALD SURGICAL COMPANY, INC.
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GRACE MANUFACTURING, INC.; 614 sr 247; russellville AR 72802
• MDR Report Key: 10689741
• MDR Text Key: 211666255
• Report Number: 10689741
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2020

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: 25821-06
• Device Catalogue Number: CET107A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2020
• Date Report to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA