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

Model Number 25821-06

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2020

Event Type  malfunction  

Event Description

Hospital reported: 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): 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: 10864665
• MDR Text Key: 219567138
• Report Number: 1818662-2020-00003
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 10801334003913
• UDI-Public: 10801334003913
• 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: 09/01/2020

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
• Device Lot Number: 27258
• 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: 10/26/2020
• Initial Date FDA Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2019
• 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: 84 YR