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

Model Number A22251C

Device Problem Material Integrity Problem (2978)

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

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.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 or if the device is returned at a later time, this report will be supplemented.

Event Description

Olympus was informed that during a hysteroscopic resection endometrial ablation procedure, part of the insulation on both sides of the loop wire (insulated distal tip) approximately 3-4mm nearest the roller ball electrode, came off during surgery.The current settings were set at 180 cut and 100 coag.The physician confirmed that no piece of the insulation was left inside the patient.There was no patient injury reported.The procedure was successfully completed using a different but similar device.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.The device was returned to olympus for evaluation.The evaluation confirmed the user's reported phenomenon.A visual inspection under a microscope revealed the insulation covering appeared partially detached and melted (showing signs of thermal damage) on both sides of the distal tip.The accessories used with the device were not returned for investigation.The exact cause of the reported event could not be conclusively determined at this time; however, based on the investigation findings, the most likely cause of the reported phenomenon could be attributed to excessive force or metal on metal contact during the high frequency (hf) activation.In addition, the recommended use for this device is for coagulation and vaporization purposes; therefore, incorrect application of the device could not be ruled out as a contributing factor to the reported event.

• Brand Name: HF RESECTION ELECTRODES
• Type of Device: HF RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER AND IBE GMBH; kuehnstrabe 61, 2045; hamburg, ; GM
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5085870
• MDR Text Key: 26493859
• Report Number: 2951238-2015-00444
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K903323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: A22251C
• Device Catalogue Number: A22251C
• Device Lot Number: 14336P02L001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2014
• 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