MAUDE Adverse Event Report: GREENWALD SURGICAL COMPANY, INC. GREENWALD SURGICAL CO, INC.; BALL TIP ELECTRODE FOR RIGID CYSTOSCOPES

Model Number	25910-06
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Describe the evento or problem: urologist using bugby ball tip electrode.When he removed it from the patient, he noticed the ball tip was missing.Upon inspection, the surgeon located the ball tip adhered to the bladder.He was able to retrieve the ball tip with no harm to the patient.What was the original intended procedure? : cystoscopy, bladder biopsy and fulgeration.What problem did the user have : device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: GREENWALD SURGICAL CO, INC.
• Common Device Name: BALL TIP ELECTRODE FOR RIGID CYSTOSCOPES
• Manufacturer (Section D): GREENWALD SURGICAL COMPANY, INC.; 2688 dekalb street; lake station IN 46405 1519
• MDR Report Key: 11814297
• Report Number: 1818662-2021-00001
• Device Sequence Number: 14542221
• Product Code: FAS
• UDI-Device Identifier: 10801334000806
• UDI-Public: (01)10801334000806
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933173
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/01/2021

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: 25910-06
• Device Catalogue Number: RET107K
• Device Lot Number: 28468
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR