MAUDE Adverse Event Report: RICHARD WOLF GMBH WORKING ELEMENT ACTIVE MONO 12/30°

Model Number 8674.205

Device Problem Temperature Problem (3022)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

Rwmic submitting report on behalf of rw (b)(4) (manufacturer).As different products were used, the instructions for use of the products used in combination were reviewed.The burning was most likely caused by leakage current flowing through the patient's body in small quantities during each rf application.If the patient's body is touched by a small area during hf activation, e.G.With the fingertip, the high current density may cause combustion.In order to largely avoid the well-known phenomenon of burning by 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 activation.Device labeling was reviewed for patient code and device codes, see below: caution! take care not to use the wrong irrigation fluid! caution when using high conductivity irrigation fluid in the case of monopolar hf applications! increased danger of patient leakage currents, no function of the hf instrument.The user must choose the irrigation fluid as required by the application.The irrigation fluid must have a low electrical conductivity for monopolar hf applications.Do not use saline (nacl solution) for monopolar hf applications.Caution! danger of elevated temperatures when working without irrigation fluid! injuries to the mucous membrane due to excessive temperatures endanger the patient.Activate the electrode only while it is immersed in irrigation fluid and under continuous irrigation.Warning! danger of electric shock! patient leakage currents can add up if the endoscopes are combined with other powered endoscopic accessories.Make sure that the combinations do not exceed the permissible patient leakage currents.(b)(4) considers this report closed.

Event Description

On november 07, 2018, richard wolf medical instruments corporation (rwmic) received a report from richard wolf (b)(4) involving the following devices: 815.052 lot 523/573 (mdr 9611102-2018-00015), 815.032 lot 006/086 (mdr 9611102-2018-00016), 8674.205 lot 1259038 (this mdr), 8680.205 lot 1255367 (mdr 9611102-2018-00018), 8654.204 lot 1202777 (mdr 9611102-2018-00019).It was reported that the patient suffered third degree burn on the right finger due to hf application.The device was returned to the manufacturer for evaluation.The inspection showed that the cause of the fault described by the user cannot be traced back to the working elements or hf connection cable mono.Probable root cause was determined to be use error.No defects were found in the medical devices.In conclusion, the combustion was not caused by a faulty hf device or accessory.

• Brand Name: WORKING ELEMENT ACTIVE MONO 12/30°
• Type of Device: WORKING ELEMENT ACTIVE MONO 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8363746
• MDR Text Key: 136927515
• Report Number: 9611102-2018-00017
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 8674.205
• Device Catalogue Number: 8674.205
• Device Lot Number: 1259038
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other