MAUDE Adverse Event Report: SURGICAL INNOVATION CANTER/ OLYMPUS CORPORATION OF AMERICA OLYMPUS PLASMA BAND; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22721S

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2019

Event Type  malfunction  

Event Description

Olympus plasma and plugged into machine and did not activate.Being utilized for a turpt procedure.(b)(4).

• Brand Name: OLYMPUS PLASMA BAND
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): SURGICAL INNOVATION CANTER/ OLYMPUS CORPORATION OF AMERICA
• MDR Report Key: 8767789
• MDR Text Key: 150523734
• Report Number: MW5087905
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/20/2023
• Device Model Number: WA22721S
• Device Lot Number: 1000026575
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 77