MAUDE Adverse Event Report: LAMIDEY NOURY MEDICAL BIPOLAR CUTTING LOOP/THIN; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Catalog Number MV1S

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2023

Event Type  malfunction  

Event Description

Bipolar electrode used for bladder tumor resections was plugged in and did not work.The electrode was unplugged, and the machine was turned off and restarted.Once the machine was turned back on, the electrode was reinserted and still did not work.A new electrode was obtained and worked to complete the case.The non working electrode was disposed of and is not available for inspection.

• Brand Name: BIPOLAR CUTTING LOOP/THIN
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): LAMIDEY NOURY MEDICAL
• MDR Report Key: 16552523
• MDR Text Key: 311513078
• Report Number: MW5115776
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2023

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 Expiration Date: 06/29/2023
• Device Catalogue Number: MV1S
• Device Lot Number: 2226-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White