MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; WORKING ELEMENT PASSIVE MONOPOLAR

Model Number 8654224

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

Rwmic considers this case open.The manufacturer and user facility will be contacted to collect missing information.A follow up report will be submitted upo receipt of new or additional information.

Event Description

On (b)(6) 2020, the user facility reported the following to richard wolf medical instruments corporation (rwmic): the working element was burned during a case.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? no.Did the issue put the patient at risk? no.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? yes.

Event Description

It was reported that on (b)(6) 2020 the user facility reported the following to rwmic: the working element was burned during a case.

Manufacturer Narrative

Follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: the following fields have changed information: b4, b5, d10, f7, f11, f13, g7, h2, h3, h6, h10.New information: results of device evaluation: the device was visually and electrically tested/evaluated.The reported condition, working element was burning during case, was confirmed during evaluation.Probable root cause was thought to be caused by short electric from electrode.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 for cautions and warnings: ifu includes a caution for device combinations possible injury of the patient, user or others as well as possible damage to the product.Joint use of the different products is only allowed if the intended uses and relevant technical data (such as working length, diameter, peak voltage, etc.) are the same.Make sure you observe the manuals of the products used in conjunction with this product.Also follow the "instructions on hf applications", order no.: ga- s 002 as well as the hf device manufacturer's instructions.Ifu includes warnings about hf application warning! danger of injury if the hf instrument is not visible through the scope! inadvertent tissue damage as well as damage to the distal end of the endo-scope and parts of the instrument is possible.Use hf instruments within the specifications (dielectric strength, voltage strength, mode).Activate hf instruments only after the live part conducting hf current has become fully visible in the field of view of the endoscope and touches the intended area to be treated.Warning! danger of explosion if the electrode is activated in an air or gas bubble (e.G.Near the top of the bladder)! this may result in bladder or uterus wall injuries.Activate the hf current only: "if the electrode is in the field of view and in irrigation fluid", if the required tissue contact is guaranteed.We recommend the following power settings: reprocessable electrodes, sterile electrodes, discardable (for single use); cutting mode: 120 - 180 watts coagulation mode: max.100 watts; coagulation mode: max.100 watts; evap electrodes; cutting mode (vaporization): 200 - 230 watts coagulation mode: max.100 watts; coagulation mode: max.100 watts.Ifu includes cautions about using with irrigation fluid caution! irrigation fluids can be electrically conductive! the user must choose a low- conductivity irrigation fluid suitable for the application.Do not use nacl (saline) for hf applications.Caution! temperature increase when working without irrigation fluid! injuries of the mucous membrane as a result of excessive temperatures endanger the patient.Activate the electrode only in irrigation fluid and under continuous- irrigation.Rwmic considers this case closed.Should additional information become available a follow up report will be submitted.Attachment: [ga-d345 usa_4.0 (11-0484).Pdf].

• Brand Name: E-LINE
• Type of Device: WORKING ELEMENT PASSIVE MONOPOLAR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10276320
• MDR Text Key: 242433489
• Report Number: 1418479-2020-00013
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207018736
• UDI-Public: 04055207018736
• Combination Product (y/n): N
• PMA/PMN Number: K980302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/11/2020,08/07/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: 8654224
• Device Catalogue Number: 8654.224
• Device Lot Number: 179R13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Distributor Facility Aware Date: 05/19/2020
• Date Report to Manufacturer: 08/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other