MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22702S

Device Problems Therapeutic or Diagnostic Output Failure (3023); Activation Failure (3270)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

Olympus bipolar machine not functioning for procedure.New maching obtained, still issue.Obtained new plasma loop and it worked.Appears plasma loop the issue.No injury and no significant delays.

• Brand Name: OLYMPUS
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 3500 corporate pkwy.; center valley PA 18034
• MDR Report Key: 17216215
• MDR Text Key: 318026964
• Report Number: 17216215
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085325
• UDI-Public: (01)14042761085325(11)230125(17)251210(10)1000110122
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22702S
• Device Catalogue Number: WA22702S
• Device Lot Number: 1000110122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2023
• Date Report to Manufacturer: 06/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA