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

Model Number APC 2

Device Problem Output Problem (3005)

Patient Problem Bowel Perforation (2668)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

The apc/esu system was returned and thoroughly inspected/tested.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.In addition, no anomalies were found in either of the device history record (dhr) of the involved devices.In conclusion, no equipment problems occurred that would have caused or contributed to the reported event.Per the reported information, the probe was activated when contacting the bowel wall.The probe's use (i.E., treating tissue with argon plasma) is a non-contact modality and activation while contacting the tissue most likely caused the perforation.Erbe usa, inc.Is now closing the file on this event.

Event Description

It was reported that an erbe system, argon plasma coagulator (apc) with an electrosurgical unit (esu/generator, model vio 300 d, part number (p/n) 10140-000, serial number (b)(4)) was involved in a patient incident.A colonoscopy was being performed to remove a polyp.Initially a filter intergrated argon plasma coagulation (fiapc) probe didn't work; therefore, another probe was exchanged.However, when activating this probe it was sticking to the intestinal wall (on the left side) which caused a perforation.Surgical intervention was performed to close the perforation.No further information was provided in regards to the patient.

• Brand Name: ERBE APC 2
• Type of Device: ARGON PLASMA COAGULATOR
• 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
• MDR Report Key: 9129376
• MDR Text Key: 165759148
• Report Number: 9610614-2019-00022
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K024047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2019

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: APC 2
• Device Catalogue Number: 10134-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Device Age: 10 YR
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2009
• 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): Required Intervention
• Patient Age: 50 YR