MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BIPOLAR APPLICATOR "CELON PROCURVE V"; ELECTRODE, PROBE, BIPOLAR APPLICATOR

Model Number	WB990207
Medical Device Problem Code	Component Falling (1105)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.However, based on the reported information, the most likely cause of the reported event can be attributed to operator error.The instruction manual provides instructions in the ¿preparing the bipolar applicator¿ section (section 4.5) which states to ¿remove the protective cover from the tip of the bipolar applicator.¿ if the device is returned to olympus for evaluation, this report will be supplemented accordingly.
Event or Problem Description
Olympus was informed that after an rf vnus procedure, the protective covering of the device was observed inside the patient.After the procedure, the doctor performed an ultrasound on the patient and observed something abnormal in the patient's leg.The patient was rushed to a local hospital and a ct scan was performed, however, there was foreign object found.The patient was then brought back to the user facility from which the doctor confirmed the foreign object which slightly regressed in the patient's right leg.The olympus sales representative asked the doctor if he had removed the protective covering from the device which the doctor confirmed that he did not remove the protective covering prior to procedure.The patient was then put under local anesthesia and a surgical intervention was performed.The protective covering was removed from the patient¿s leg successfully.The patient recovered and was discharged on the same day.The patient was reported to be doing fine and is scheduled for a follow up at a later date.Additionally, the doctor used a first device and the machine was not turning the device on.A second device was used and the same thing occurred.A 3rd kit was used to complete the procedure.1 of 3 devices.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to the initial report event from additional information from the olympus sales representative, and to update the following sections: pma/510k, if follow-up, what type was observed inside the patient right leg.During the procedure, an audible error sounded when the footswitch was depressed.The device was withdrawn from the patient and a second like device was opened as the physician believed it may have been a bad applicator device.An ultrasound confirmed there was the foreign object in the patient¿s vein.The olympus sales representative was onsite and identified the foreign object as the plastic covering from the applicator.The physician made an incision and attempted to retrieve the plastic covering from the patient but was unsuccessful.The patient was transported to a nearby hospital for multiple diagnostic imaging.After multiple imaging approaches, the plastic covering was eventually located as the plastic covering was noted to have slightly regressed.The patient and doctor returned returned back to the facility.The plastic covering was removed and the vein was treated using a third device.The patient recovered and was discharged on the same day.The patient was reported to be doing fine and is scheduled for a follow up at a later date.Additionally, manufacturing and quality control review was performed for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation results.The device was returned without it¿s protective cover.A visual inspection of the device noted the shiftable rubber ring was set at 9cm marker.The flexible catheter is slightly bent at the white bar.The distal end has slight scratches and device was returned as used.Based on the evaluation, the reported complaint is likely due to user error.The instruction manual (section 4.5) states, "preparing the bipolar applicator": remove the protective cover from the tip of the bipolar applicator.Inspect the bipolar applicator, its hf cable and the plug for damage.Do not use a damaged bipolar applicator.¿ also, ¿bending and twisting the tip of the bipolar applicator can damage the joints, which results in unnoticed destruction or malfunction.¿.

• Brand Name: BIPOLAR APPLICATOR "CELON PROCURVE V"
• Common Device Name: ELECTRODE, PROBE, BIPOLAR APPLICATOR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• MDR Report Key: 7657990
• Report Number: 2951238-2018-00389
• Device Sequence Number: 134780
• Product Code: GEI
• UDI-Device Identifier: 04042761085014
• UDI-Public: 04042761085014
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K172535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WB990207
• Device Catalogue Number: WB990207
• Device Lot Number: 17125P07L001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 07/03/2018; 08/02/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/18/2018; 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention