MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 300 D; ELECTROSURGICAL UNIT

Model Number VIO 300 D

Device Problem Defective Component (2292)

Patient Problem Shock (2072)

Event Date 11/05/2021

Event Type  malfunction  

Event Description

It was reported that an incident occurred with the electrosurgical unit (esu/generator) during a complex soft tissue procedure to address charcot foot disease.The esu was used with bipolar forceps; straight, 16.5cm, tip 1mm, blunt (part number 20195-039, lot number ij05).A description of the other accessories used in the procedure was not provided.The esu settings were bipolar soft mode, effect 5, 50 watts.When approaching the tissue, a massive spark occurred between the branches of the forceps and there was a loud "bang" sound.The surgeon had the feeling that his entire right arm, that was holding the instrument, was in a kind of "electrical force field".There was a thud in the physician's neck and there was physical discomfort for a short time (approximately 1 minute).An ecg was done and a circulatory check was carried out on the surgeon.Both of the test were normal.There were no other injuries to the physician and the patient was uninjured.

Manufacturer Narrative

The esu as well as the bipolar forceps and cable were returned and thoroughly inspected/ tested.The findings were as follows: esu the evaluation included an electrical safety check, a functional check of each of the equipment's features and a power output check.The generator was/is within specifications and all features were/are functioning properly.The unit's chronological log at the time of the event was reviewed and there were no problems with the esu.In conclusion, there were no issues with the generator that would have caused or contributed to the event.Bipolar forceps and cable an inspection of the bipolar forceps revealed that the insulation of the forceps at the proximal end (end of the connector area) and the adhesive coating were damaged.The rilsan coating and the branches of the forceps showed clear signs of reprocessing (cleaning, etc.) and use.A material/manufacturing defect couldn't be determined.The bipolar cable show traces of melting inside the connector on the instrument side.The cable damage was probably caused by the compromised bipolar forceps.Most likely, there were many factors involved in the reported incident.However, it appears that the insulation breach in the proximal instrument area caused electrical current to be diverted/directed into the surgeon.This resulted in the reported event involving the physician.The bipolar forceps notes on use expressly states that the instrument must be checked before each use, including all insulation and mechanical damage and, if defective, the product must not be used.No trends have been identified and erbe usa, inc.Is now closing the file on this event.

• Brand Name: ERBE VIO 300 D
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse; tubingen 72072 ; GM
• Manufacturer (Section G): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse; tubingen 72072 ; GM
• Manufacturer Contact: john tartal ; 2225 northwest parkway; marietta, GA 30067-9317 ; 7709554400
• MDR Report Key: 12882196
• MDR Text Key: 285488765
• Report Number: 9610614-2021-00021
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VIO 300 D
• Device Catalogue Number: 10140-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male