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

Model Number A22251C

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

The devices referenced in this report will not be returned to olympus for evaluation due to being discarded.The exact cause of the reported event could not be conclusively determined at this time; however, this type of damage is most likely related to the operator's technique.The instruction manual contains several caution statements in an effort to prevent damage to the electrode."when attaching the electrode, make sure not to push it too forcefully into the working element.When checking the locking of the electrode, make sure not to pull too forcefully.Otherwise the electrode may be damaged.Additionally, improper use of hf current can cause endogenous or exogenous burns, and explosions.Set the cutting current to 200 - 300 w for vaporization." if additional information is received this report will be supplemented accordingly.Please cross reference mfr.Report numbers: 2951238-2016-00019, 2951238-2016-00020, 2951238-2016-00021.

Event Description

Olympus was informed that during a transurethral resection of the bladder (turb) procedure, four resecting electrode roller tips broke off.It was reported that no device fragment was left inside the patient.The non-olympus generator settings were 270 cut and 60 coag.The procedure was successfully completed using a different but similar device.There was no patient injury reported.No additional information was provided.This is four of four reports.

• Brand Name: HF RESECTION ELECTRODES
• Type of Device: HF ELECTRODE,
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5376653
• MDR Text Key: 36290188
• Report Number: 2951238-2016-00022
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22251C
• Device Catalogue Number: A22251C
• Device Lot Number: 14227P02L001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2014
• 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: VALLEY LAB ESU/ SERIAL NO. UNK