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

Model Number	25830-05
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
• Common Device Name: CET 107K, 5 FRENCH
• Manufacturer (Section D): GREENWALD SURGICAL COMPANY, INC.; 2688 dekalb street; lake station, in
• MDR Report Key: 10317048
• Report Number: 1818662-2020-00001
• Device Sequence Number: 16881851
• Product Code: FAS
• UDI-Device Identifier: 10801334001421
• UDI-Public: 10801334001421
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1