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

Model Number	25821-05
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
• Common Device Name: ELECTRODE, ELECROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GREENWALD SURGICAL COMPANY, INC.; 2688 dekalb street; lake station IN 46405 1519
• MDR Report Key: 10864370
• Report Number: 1818662-2020-00002
• Device Sequence Number: 16477945
• Product Code: FAS
• UDI-Device Identifier: 10801334003906
• UDI-Public: 10801334003906
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K933174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR