MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS-AMCI BUGBEE ELECTRICAL CORD; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number C650-129A

Device Problems Disconnection (1171); Sparking (2595)

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

Event Date 07/16/2022

Event Type  malfunction  

Event Description

During a surgical procedure-cystoscopy with fulguration, a spark occurred at the junction of the bugbee electrical cord and the bugbee electrode.The male adapter on the bugbee cord became completely disconnect during the spark.Fda safety report id #(b)(4).

• Brand Name: BUGBEE ELECTRICAL CORD
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS-AMCI
• MDR Report Key: 15217115
• MDR Text Key: 297953619
• Report Number: MW5111454
• 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: 08/10/2022

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: C650-129A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male