MAUDE Adverse Event Report: RICHARD WOLF GMBH (GERMANY) WORKING ELEMENT ACTIVE BIPO 0/12/30, CLOSED, COMPATIBLE WITH TELESCOPES Ø4MM,; WORKING ELEMENT, ACTIVE, BIPO.

Model Number 8680.205

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Burn(s) (1757); Electrocution (1827)

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

The review by the responsible department showed that the case of failure described by the user is not causally attributable to the working element.During the review it was determined that there were traces of powder on the lock housing.This fact indicates an electrical short.As there are different devices in use during the application it is important to pay attention to the instructions for use of the devices used in combination.The reason for the situation must be assessed in a differentiated manner.Therefore we consulted erbe company, the manufacturer of the hf device vio 300d.Erbe company concluded as follows: the user worked with vio 300d with the settings bipolar cut+effect 4 and bipolar soft+effect 4.As accessories a cable and an electrode from richard wolf company were used.We do not know which neutral electrode was used and where it was installed.According to the stk-protocol from april 20, 2018 the functionality and the safety of the hf device erbe vio 300d (article number 10140-000, serial (b)(4)) were guaranteed.We conclude that the burns were not caused by a defective hf device or the accessories.The burns were probably caused by a leakage current, which is flowing through the body of the patient in small quantities during a hf application.A small-area contact, for example with a fingertip, during the hf activation may lead to burns caused by the high current density.In the present case a leaked out conductive fluid (for example nacl solution) at the venous catheter may have decreased the contact resistance from skin to skin.To largely avoid the well-known phenomenon of burns by a leakage current it is recommended to keep the effect of the hf current as low as possible and to avoid skin to skin contact during the activation.In the ifu of vio 300d the topic "burns caused by leakage current" is explicitly pointed out.In our opinion the injury of the anesthesia nurse could have been avoided by professional application.If required employees of erbe elektromedizin company gladly impart sound knowledge about the electrosurgery during specialist lectures and trainings.A correlation between the application of the hf device and the incident can be retraced.From our point of view there are sufficient notes in the ifu ga-d 342 (chapter 8) concerning the visual inspection and the function control.The ifu refers to controls to be carried out.The reclaimed defect on the working element was caused by insufficient accuracy during the control of the electrode.In the risk assessment b6 r02 potential risks with the corresponding extend of damage and the expected likelihood of occurrence were regarded and consequently assessed as an acceptable risk.This assessment is still valid in consideration of the current case.Rw (b)(4) considers this report closed.If any additional information regarding this event is received, a follow up report will be sent to the fda.(b)(4).

Event Description

During bipolar cutting and coagulation during a bipolar tur, the anesthesiologic sister just below the puncture site of the venous catheter on the patient's left forearm burned her fingertip of the ring finger to the right.About this catheter was administered a saline infusion.The jumpers during the procedure found only a current delivery at the described location of the patient.Left arm of the patient, parallel to resection of the left prostate valve.In other parts of the patient's body no current delivery was detected.Type: 8680.205 working element active bipo 0/12/30, manufactured date: 15 dec 2015, lot size: (b)(4) units, purchase date: 19 dec 2016.

• Brand Name: WORKING ELEMENT ACTIVE BIPO 0/12/30, CLOSED, COMPATIBLE WITH TELESCOPES Ø4MM,
• Type of Device: WORKING ELEMENT, ACTIVE, BIPO.
• Manufacturer (Section D): RICHARD WOLF GMBH (GERMANY); registration number 9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH (GERMANY); registration number 9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; 32 pforzheimer street; knittlingen, germany
• MDR Report Key: 7522540
• MDR Text Key: 109104482
• Report Number: 9611102-2018-00009
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207042939
• UDI-Public: 04055207042939
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2018

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: 8680.205
• Device Catalogue Number: 8680.205
• Device Lot Number: 1327688
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1