MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS ESG-400 HIGH FREQUENCY ELECTROSURGICAL GENERATOR; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Model Number ESG-400

Device Problems Sparking (2595); Noise, Audible (3273)

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

Event Date 03/13/2020

Event Type  Injury  

Event Description

During a cystoscopy, transurethral bipolar vaporization of prostate procedure, a loud "pop" was heard and sparks were generated at the point of connection on the cystoscope.The grey reusable bipolar cord was burned and severed into two pieces - one piece remained connected to the cystoscope and the other was thrown in front of and across the surgeon's face.There was no contacted with the pt, and no harm to the pt.

• Brand Name: OLYMPUS ESG-400 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS ; 3500 corporate pkwy ; center valley PA 18034 0610
• MDR Report Key: 10082435
• MDR Text Key: 192019908
• Report Number: MW5094644
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESG-400
• 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?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 81