MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS HF RESECTION ELECTRODES

Model Number A22206C

Device Problem Break (1069)

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

Event Date 05/01/2014

Event Type  malfunction  

Event Description

Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the loop on the device broke off inside the pt.The procedure was completed with a second electrode.No additional info was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide additional info based on the eval of the device.The eval confirmed that the electrode was damaged and broken.It was noted that the loop wire had broken off at both sides of the red filter section, and there was evidence of thermal damage and melting at the damaged areas.The device has been forwarded to the original equipment mfr for further investigation.If additional info is available at a later time, this report will be supplemented accordingly.

• Brand Name: OLYMPUS HF RESECTION ELECTRODES
• Type of Device: RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hanburg 2204 5; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 2204 5; GM 22045
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4098928
• MDR Text Key: 21724461
• Report Number: 2951238-2014-00422
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/23/2014

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: A22206C
• Device Catalogue Number: A22206C
• Device Lot Number: 13282P02L001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2014
• Initial Date FDA Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODEL#: A22206C, LOT#: 13282P02L001,; MFR REPORT# 2951238-2014-00238; MODEL#: A22206C, LOT#: 13282P02L001,; MFR REPORT# 2951238-2014-00237