MAUDE Adverse Event Report: GREENWALD SURGICAL COMPANY, INC. GREENWALD SURGICAL COMPANY, INC.; ELECTRODE, ELECROSURGICAL, ACTIVE, UROLOGICAL

Model Number 25821-05

Device Problems Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2020

Event Type  malfunction  

Event Description

Hospital reported: 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, ELECROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GREENWALD SURGICAL COMPANY, INC.; 2688 dekalb street; lake station IN 46405 1519
• Manufacturer (Section G): GREENWALD SURGICAL COMPANY, INC.; 2688 dekalb street; lake station IN 46405 1519
• Manufacturer Contact: liz birge ; 614 sr 247; russellville, AR 72802 ; 4799685455
• MDR Report Key: 10864370
• MDR Text Key: 219374990
• Report Number: 1818662-2020-00002
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 10801334003906
• UDI-Public: 10801334003906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2020

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: 25821-05
• Device Catalogue Number: CET107A
• Device Lot Number: 27086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR