MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE VIO 3; ELECTROSURGICAL UNIT

Model Number VIO 3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/03/2024

Event Type  Injury  

Event Description

It was reported that a patient incident occurred with the electrosurgical unit (esu/generator) during a gastric endoscopic submucosal dissection (esd).The esu was used with an erbe hybridknife "i" type and an olympus coag grasper.The settings were endocut i, 3-3-2 and dry cut effect 4 as well as forced coag, effect 3 and soft coag.After the procedure, burn/necrosis marks were discovered on the patient's right index finger.A photograph showed that there were two (2) burn marks close to each other.One of the marks was black as well as red in color and approximately 2 cm x 0.5 cm.The other was smaller (about 1 cm x 0.5 cm) with small speckled black spots.Per the account, the finger touched the "fluro bed metal skirt" during the procedure.No information was provided regards to any treatment given to address the burn/necrosis marks.

Manufacturer Narrative

The esu was thoroughly inspected/tested.The unit was found to be functioning as intended.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 working properly.In addition, no anomalies were found in the device history record (dhr) of the involved device [note: two (2) monopolar cables, part number 20192-135, lot numbers 1219 and 1221 were also returned as part of the evaluation.They both were functioning as intended.].In conclusion, no equipment problem was found that would have caused or contributed to the incident.Based upon the reported information, the patient's finger encountered a conductive metallic object (i.E., the fluro bed metal skirt) at the site of the injury.Due to high current density in a small area at the site, the metal became hot which resulted in the thermal damage (note: there is a warning in the user manual addressing this type of situation.).The account is being made aware of the findings.No trends have been identified and erbe usa, inc.Is now closing the file on this event.

• Brand Name: ERBE VIO 3
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse 17; tubingen, germany 72072 ; GM 72072
• Manufacturer (Section G): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse 17; tubingen, germany 72072 ; GM 72072
• Manufacturer Contact: john tartal ; 2225 northwest parkway; marietta, GA 30067-8764 ; 7709554400
• MDR Report Key: 18545597
• MDR Text Key: 333273153
• Report Number: 9610614-2024-00006
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2024

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 3
• Device Catalogue Number: 10160-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• 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: 50 YR
• Patient Sex: Male