MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS HF CABLE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA00014A

Device Problems Break (1069); Sparking (2595)

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

Event Date 09/20/2017

Event Type  malfunction  

Event Description

A patient was undergoing a transurethral resection of the bladder (turb).An olympus esg-400 unit was being used when the plasma cord broke and sparked from the working element.

• Brand Name: OLYMPUS HF CABLE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 2400 ringwood ave.; san jose CA 95131
• MDR Report Key: 7107735
• MDR Text Key: 94522080
• Report Number: 7107735
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: WA00014A
• Device Catalogue Number: WA00014A
• Other Device ID Number: PLAMA CAUTERY CORD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 73 YR