MAUDE Adverse Event Report: GRACE MANUFACTURING, INC. BALL TIP ELECTRODE FOR RIGID CYSTOSCOPES; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	25910-06
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: BALL TIP ELECTRODE FOR RIGID CYSTOSCOPES
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GRACE MANUFACTURING, INC.; 614 sr 247; russellville AR 72802
• MDR Report Key: 11618526
• Report Number: 11618526
• Device Sequence Number: 3021020
• Product Code: FAS
• UDI-Device Identifier: 10801334000806
• UDI-Public: (01)10801334000806
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2021
• Report Date (Section F): 04/05/2021

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: 1028468
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/05/2021