MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24 - 28 FR.,

Model Number A22251C

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.The cause of the reported event could not be determined; 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.¿.

Event Description

Olympus was informed that during a hysteroscopy endometrial ablation minera intrauterine system replacement procedure, the gray rubber sheath on the side of the electrode ball came off and fell inside the patient.The device fragment was retrieved and no pieces were left inside the patient.The procedure was completed using a different electrode.No patient injury.

Manufacturer Narrative

The high frequency (hf) resection electrode was returned to olympus for evaluation.The evaluation confirmed the reported device damage.A visual inspection under a microscope revealed that the insulation coating on both sides of the distal tip was found melted, charred, and exposing wires due to thermal damage.One side of the insulation was melted and missing a fragment about 1.5mm in size.The other side of the insulation was also found melted with a fragment missing about 3mm in size.All missing fragments were not returned to olympus.In addition, the electrode was tested with an olympus test working element and was able to coagulate with no problems noted.Based on the investigation findings and similar reported events, the cause of the reported device damage likely occurred if the device comes in contact with a metal or hard like material when the hf output was activated and / or used with excessive force.The instruction manual for use states, ¿hf resection electrodes are classified according to their compatibility with coagulation, cutting or vaporization.Use hf resection electrodes only for compatible applications.Replace if necessary.If the instrument is damaged or does not function properly, replace it.Risk of damaging the instrument.Make sure not to push it too forcefully into the working element.Otherwise the electrode may be damaged.¿.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24 - 28 FR.,
• Type of Device: HF-RESECTION ELECTRODE, ROLLER, 24 - 28 FR.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6183617
• MDR Text Key: 62709835
• Report Number: 2951238-2016-00957
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• 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: 14238P02L001
• Other Device ID Number: 14042761036815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• 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