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

Model Number VIO 300 D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

The esu was thoroughly inspected/tested.A technical safety check was performed on the generator.This included an electrical safety check, a functional check of each of the equipment's features, and a power output check.All features were/are functioning properly within specifications for the device.No anomalies were found in the review of the unit's device history record (dhr).In conclusion, no equipment problem was found that would have caused or contributed to the event.Most likely, it appears that during activation, the anesthesiologist became part of the electrical circuit (i.E., due to the doctor's contact with the patient, hf leakage current flowed through the patient's body to her hand) and most likely caused the burn.There are warnings in the erbe esu user manual to keep the effect of the hf current as low as possible and not to come into contact with the patient during activation.The perceived electrical shock to the patient was probably a heat sensation.However, no conclusive determination could be made [i.E., all the other non-erbe equipment (i.E., resectoscope, etc.) and accessories (i.E., loop) would need to be checked].No trends have been identified with this incident.Erbe usa, inc.Is now closing the file on this event.

Event Description

It was reported that an incident occurred with the electrosurgical unit (esu/generator) during a bipolar transurethral resection of the prostate (tur-p).The esu was used with a resection loop.Specifically, it was stated that an anesthesiologist had her hand burned, while touching the patient.Details of the burn (i.E., location, size, appearance, degree, etc.) were not provided.The clinicians suspected that the resection loop (third party manufacturer, but specifics not provided) may have been the cause of the event.As a result of the incident, an electrocardiogram (ekg) examination of the patient was carried out due to a suspected electric shock.Additionally, a blood sample was obtained to check the patient's cardiac enzymes and the patient was monitored in their intermediate care ward (extended hospital stay) under the assumption that there was a possible electrical shock to the patient.In addition, the procedure time was prolonged due to the replacement of the esu and the resection loop.Note: the esu was distributed by our parent company (erbe elektromedizin (b)(4)) to a (b)(6) medical facility.

• 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 ; 9554400133
• MDR Report Key: 10493508
• MDR Text Key: 205767665
• Report Number: 9610614-2020-00027
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VIO 300 D
• Device Catalogue Number: 10140-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Device Age: 5 YR
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• 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): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 73