MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE APC 2; ARGON PLASMA COAGULATOR

Model Number APC 2

Device Problems Output, high (1433); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Internal Organ Perforation (1987)

Event Date 10/22/2014

Event Type  Injury  

Event Description

It was reported that an erbe system; argon plasma coagulator (apc) model apc 2 with an electrosurgical generator model vio 300 d (part number 10140-100, serial number (b)(4)) was used in a procedure to treat arteriovenous malformations (avms).The settings were pulsed apc 2 mode at 20 watts.The account reported that upon activation the mode switched to forced apc and the output was too high.A perforation occurred.No further patient information was provided.

Manufacturer Narrative

A thorough evaluation on the returned system was conducted.A technical safety check was performed on each unit.This included an electrical safety check, a function check of each of the equipment's features, and a power output check.Also, the gas flow rates were measured and found to be within their acceptable ranges for the apc.All features were/are functioning properly within specifications on both devices.In addition, no anomalies were found in the device history records (dhrs) for the apc and esu.In conclusion, no erbe equipment problem was found that would have caused or attributed to the event (note: unrelated to the reported issue and to further meet the customer needs, some unrelated software update work was performed on the system upon an initial evaluation of the units).The report of higher output was not found.All outputs were within specifications.Also, a review of the system's chronological log revealed that the system was not activated in the forced apc mode as the customer reported.Twenty activations of pulsed apc mode occurred as intended within an eight (8) minute period on the date of the reported incident.Most likely there were many factors involved in the reported event.However, it appears that upon the intervention, the remaining wall did not stay intact which resulted in the perforation.Nonetheless, no conclusive determination could be made as to the cause of the incident.The account is being made aware of the findings.To further address the issue, additional in-service training is being offered to the involved medical staff.Erbe usa, inc.Is now closing the file on this event.

• Brand Name: ERBE APC 2
• Type of Device: ARGON PLASMA COAGULATOR
• 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: 4336244
• MDR Text Key: 5142478
• Report Number: 9610614-2014-00017
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APC 2
• Device Catalogue Number: 10134-000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2014
• Distributor Facility Aware Date: 10/22/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2014
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other