MAUDE Adverse Event Report: OLYMPUS AMERICA & IBE GMBH WORKING ELEMENT RESECTOSCOPE

Model Number WA22367A

Device Problem Fire (1245)

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

Event Date 03/18/2015

Event Type  malfunction  

Event Description

Olympus was informed that during an transurethral resection of the prostrate (turp) procedure, the physicians glove caught fire while using an electrosurgical unit (esu) and working element.However, it was reported that there was no patient injury.Olympus followed up with the user facility and was informed that the physician did not require any medical or surgical treatment and sustained no injury.The intended procedure was completed with another similar device.The esu, working element and hf cable will be returned to olympus for evaluation.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the event could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted as the device was returned to olympus for evaluation.The device was attached to test equipment and it was found that the electrode passage was functional and the reported phenomenon could not be confirmed.In addition, the device was checked with a test electrosurgical generator and the power output was able to be generated without any issues.The device also passed the dielectric test.A visual inspection found minor rust (corrosion) on the bottom of the hf port due to evidence of fluid invasion, which most likely caused the reported phenomenon.When the hf port was removed, brown stains (corrosion) was noted inside the teflon body.However, there was no indication of spark discharge or charring residues inside the teflon body when inspected.

• Brand Name: WORKING ELEMENT RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS AMERICA & IBE GMBH; kuehnstrasse 61 22045 ; GM 22045
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131-1700 ; 4089355002
• MDR Report Key: 4666626
• MDR Text Key: 5610367
• Report Number: 2951238-2015-00168
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2015

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: WA22367A
• Device Catalogue Number: WA22367A
• Device Lot Number: 101W-019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MODEL: WA000014A, LOT# 138W-0252
• Patient Age: 60 YR
• Patient Weight: 82