MAUDE Adverse Event Report: OLYMPUS WINTER AND IBE GMBH OLYMPUS HF RSECTION ELECTRODE, LOOP

Model Number A22206C

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

Olympus received a medwatch report stating that the tip of three electrodes broke off during a case.There was no pt harm reported.Olympus followed up with the user facility via phone and in writing in an effort to obtain additional info regarding the reported event with no results.

Manufacturer Narrative

The device referred to in this report has not been returned to olympus for eval.The exact cause of the reported event could not be conclusively determined at this time.Olympus will continue to work with the user facility to obtain more detailed info regarding this report, and if new info is received at a later time this report will be updated.

• Brand Name: OLYMPUS HF RSECTION ELECTRODE, LOOP
• Type of Device: RSECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER AND IBE GMBH; kuehnstrasse 61; hamburg 2204 5; GM 22045
• Manufacturer (Section G): 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: 4143607
• MDR Text Key: 20068037
• Report Number: 2951238-2014-00297
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/21/2014

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: 13319P02L001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2014
• Initial Date FDA Received: 08/08/2014
• 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: A22206C WITH LOT 13319P02L001 (2951238-2014-00298); A22206C WITH LOT 13319P02L001 (2951238-2014-00302)
• Patient Outcome(s): Other