MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS WORKIGN ELEMENT, PASSIVE; HF-WORKING ELEMENT, RESECTOSCOPE

Model Number WA22067A

Device Problems Sparking (2595); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

Olympus was informed that during an unknown procedure, the electrode arced and caught fire when the wire was put through the device.No additional information was provided.Olympus followed up with the user facility and it was reported that this was an isolated event and that there was no patient injury reported.The reported event occurred toward the end of the procedure, when the physician was using coag function with a vaportrode device, the device arced and a brief spark was observed.It was noted that there was a burnt mark around the release button.However, there were no flames observed or smoke coming from the device.The connection were checked and found okay.There were no other devices replaced and the intended procedure was completed.

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The evaluation confirmed the reported phenomenon of a damaged electrode.However, the evaluation was unable to determine the root cause of the broken tip, as the missing portion was not returned.A visual inspection found the electrode release button missing with black stains inside the button hole.A test electrode was used during testing to check the electrode passage and found the device working element could not lock/secure the test electrode ito position due to a damaged locking pin inside the teflon body.The high frequency (hf) connector was removed and mor charred residues was found inside the teflon body.A broken tip of the returned electrode proximal end was found stuck inside the hf connector base upon inspection.The most likely cause of the reported phenomenon is due to the damaged electrode release button could not hold the electrode properly.When the hf current was activated, a spark discharged and caused damage to the teflon body.The device was serviced and returned to the user facility.

• Brand Name: OLYMPUS WORKIGN ELEMENT, PASSIVE
• Type of Device: HF-WORKING ELEMENT, RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 2204 5; GM 22045
• Manufacturer Contact: noemi schamback ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4645327
• MDR Text Key: 5678290
• Report Number: 2951238-2015-00106
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22067A
• Device Catalogue Number: WA22067A
• Device Lot Number: 121W-0059
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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