MAUDE Adverse Event Report: SHARK; BIVAP ELECTRODE DIPO 24-26 FR

Model Number 46300243

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) considers this mdr/complaint open.(b)(4) will submit a follow up report after the device evaluation has been completed and/or new information becomes available.This is a follow-up report for rw complaint (b)(4).The initial report and first follow-up are under mdr 1418479-2021-00019 (describes product malfunction).Follow-up 2 report for mdr 1418479-2021-00019 reports on the patient information for a (b)(4).Follow-up report is to provide fda with missing information, new information, and changed information.

Event Description

Rw received a response from the user facility to medwatch questionnaire, this report is to the share those details (patient details) with the fda.The purpose of this report is to submit the patient information and other details received from the user facility as part of due diligence.Please see mdr 1418479-2021-00019 for the initial report and all the details of the device malfunction.

Event Description

The purpose of this submission is to update the report with the correct lot number.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #3 is to provide fda with new and corrected/changed information.Corrected/changed information: the following fields have changed information: d4, h4.Rwmic considers this mdr open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Event Description

The purpose of this submission is to report the results of the device investigation.According to the manufacturer, the complaint condition was verified.Physical findings: the electrode has a detached distal electrode head, with a break in the two feeding wires above the electrode head.In addition, the distal electrode head is heavily discolored and shows severe thermal wear.The changes visible on the electrode indicate damage due to the aging caused by the hf application within the intended single-use of the electrode.When using hf application, aging in phenomena occur on the applied part due to the system.This wear depends on many factors such as type of the hf generator, setting of the hf generator, tissue contact direction of use, etc.Excessive power settings on the hf generator can cause rapid wear already within one use, which can eventually lead to breakage of the applied part.The type and setting of the hf generator as well as the combination of used devices are unknown.An exact determination of the cause is not possible.Probable root cause: user error test method: visual means.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #4 is to provide fda with missing information, new information, and changed information.New information: device evaluation.Changed information: the following fields have changed information: h8 device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed: ifu contains cautions and notes for power settings, thermal damage, setting optimum power setting.If the power setting is too high above the value recommended by the manufacturer there is the risk of increased thermal damage and abrasion as well as breakage of the electrode loop (wire).Set the power to the value recommended by the hf device manufacturer.Thermal damage may be caused if the vaporization electrode is permanently activated! high levels of heat or distal wear to the electrode insulation may be the result.When using the vaporization electrode, the following should be observed: 'no permanent activation of the vaporization electrode 'activation and pause phases should be implemented in the same way as when using a cutting electrode 'the vaporization electrode should only be activated when in contact with large areas of tissue note: excessive power settings can cause clearly increased electrode wear.We recommend starting at a lower power setting to determine the optimum power setting.Hf applications caution: careful if hf output power is incorrectly selected injuries to the patient as well as damage to the product are possible.The power should be set on the basis of the surgeon's experience and training with regard to the corresponding indication.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

• Brand Name: SHARK
• Type of Device: BIVAP ELECTRODE DIPO 24-26 FR
• MDR Report Key: 12304761
• MDR Text Key: 267642804
• Report Number: 1418479-2021-00037
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/31/2022
• Device Model Number: 46300243
• Device Catalogue Number: 46300243
• Device Lot Number: 4500230737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 09/13/2021; 11/16/2021
• Supplement Dates FDA Received: 10/01/2021; 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White