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

Model Number VIO 300 D

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Necrosis (1971)

Event Date 04/22/2015

Event Type  Other  

Event Description

It was reported that a pt incident occurred during a knee endoprosthesis with the electrosurgical unit (esu/generator).The pt was in a sunpine position during the surgery and the surgery was approximately 100 minutes in duration.Upon the right knee replacement on an obese pt, necrosis was discovered on the pt's buttocks.No further info regarding the pt was provided.Note: the esu was distributed by our parent company (erbe electromedizin (b)(4)) to a (b)(6) hospital.

Manufacturer Narrative

The esu was thoroughly inspected/tested.A technical safety check was performed on the generator.This included an electrical safety check, a function 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 there were many factors involved with the pt incident such as the procedure being long, elderly/obese pt's being more susceptible to pressure to the skin, possible reaction to disinfectant used at the site, etc.However, no conclusive determination could be made as to the cause of the event.No trends have been identified with this incident.Erbe usa, inc is now closing the file on this event.

• Brand Name: ERBE VIO 300 D
• Type of Device: ELECTROSURGICAL
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; tuebingen ; GM
• Manufacturer (Section G): ERBE ELEKTROMEDIZIN GMBH; waldhoernlestrasse 17; tuebingen 7207 2; GM 72072
• Manufacturer Contact: john tartal ; 2225 northwest parkway; marietta, GA 30067 ; 7709554400
• MDR Report Key: 4834976
• MDR Text Key: 5934013
• Report Number: 9610614-2015-00006
• 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,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• 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?: Yes
• Date Returned to Manufacturer: 04/30/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2015
• Distributor Facility Aware Date: 04/22/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2015
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2013
• 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: 79 YR
• Patient Weight: 92