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

Model Number 25821-05

Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 02/18/2020

Event Type  malfunction  

Event Description

The tip of the catheter has a metal end piece that broke off during the procedure.This device was being used in a cystoscopy case and the tip of the bugbee broke off.I am unsure of the correlation of the sterilization and device failure.Our internal central processing department has not identified a possible causation.This event was a metal type of catheter used during the cystoscopy.The packaging sequestered and sent to me indicated sterilization roll.But it (the event) is about a 16 inch metal catheter.

• 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: 10619379
• MDR Text Key: 209572322
• Report Number: 10619379
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25821-05
• Device Catalogue Number: CET107A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29930 DA