MAUDE Adverse Event Report: GREENWALD SURGICAL COMPANY, INC. GREENWALD SURGICAL COMPANY, INC.; CET 107K, 5 FRENCH

Model Number 25830-05

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

Patient Problem No Code Available (3191)

Event Date 04/23/2020

Event Type  malfunction  

Event Description

During a procedure the electrode's tip fell off or disintegrated.The doctor tried to locate and retrieve the ball tip to no avail.The patient stayed in recovery longer for evaluation and the patient was released.

• Brand Name: GREENWALD SURGICAL COMPANY, INC.
• Type of Device: CET 107K, 5 FRENCH
• Manufacturer (Section D): GREENWALD SURGICAL COMPANY, INC.; 2688 dekalb street; lake station, in
• Manufacturer (Section G): GREENWALD SURGICAL COMPANY, INC.; 2688 dekalb street; lake station, in
• Manufacturer Contact: liz birge ; 614 sr 247; russellville, ar ; 9685455
• MDR Report Key: 10317048
• MDR Text Key: 202020382
• Report Number: 1818662-2020-00001
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 10801334001421
• UDI-Public: 10801334001421
• 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
• Type of Report: Initial
• Report Date: 06/10/2020

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: 25830-05
• Device Catalogue Number: CET107K
• Device Lot Number: 27022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1