MAUDE Adverse Event Report: OLYMPUS WINTER AND IBE GMBH OLYMPUS HF-RESECTION ELECTRODE

Model Number WA22302D

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2015

Event Type  malfunction  

Event Description

Olympus was informed that towards the end of a turp (transurethral resection of the prostate) procedure, the physician hit a bladder stone and caused the electrode loop to break inside the pt.The broken loop was retrieved immediately using an olympus grasper.There was no pt injury reported.The procedure was successfully completed using the same device.

Manufacturer Narrative

The device was discarded by the user facility and will not be returned to olympus for eval.Based on the info provided by the user facility, this device damage was most likely caused by user error.This type of damage can result when the electrode loop comes in contact with metal or hard like materials during the high frequency (hf) activation.

• Brand Name: OLYMPUS HF-RESECTION ELECTRODE
• Type of Device: ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER AND IBE GMBH; kuehnstrasse 61; hamburg 2204 5; GM 22045
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4502566
• MDR Text Key: 19986154
• Report Number: 2951238-2015-00022
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 13163O01L003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2015
• 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