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

Model Number 25910-06

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2021

Event Type  malfunction  

Event 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
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GRACE MANUFACTURING, INC.; 614 sr 247; russellville AR 72802
• MDR Report Key: 11618526
• MDR Text Key: 243985061
• Report Number: 11618526
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 10801334000806
• UDI-Public: (01)10801334000806
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2021,04/01/2021

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
• Device Operator: Health Professional
• Device Model Number: 25910-06
• Device Catalogue Number: RET107K
• Device Lot Number: 1028468
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA