MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE APC 3; ARGON PLASMA COAGULATOR

Model Number APC 3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bowel Perforation (2668)

Event Date 10/12/2022

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 functional 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.Most likely, there were many factors involved in the incident.However, based upon the provided documentation there are two possible scenarios: 1.The use of the different mode (including other non-typical settings employed) resulted in excessive coagulation and the perforation (as concluded by the user).2.During the intervention work in the cecum (a very thin-walled area), the remaining tissue of the bowl did not stay intact which resulted in the perforation.In conclusion, no determination could be made as to the cause of the event.No trends have been identified.Erbe usa, inc.Is now closing the file on this event.

Event Description

It was reported that an erbe system, argon plasma coagulator (apc)/electrosurgical unit (esu/generator, model vio 3, part number (p/n) 10160-000, serial number (b)(4) system was involved in a patient incident during a colonoscopy.No information was provided in regards to other equipment or accessories involved in the procedure.However, it was stated that the forcedapc mode was inadvertently used instead of the pulsedapc mode that is in their "cecum program".Nevertheless, while coagulating with argon plasma in the cecum, a perforation occurred.No details were conveyed to erbe in regards with the patient's condition (including additional medical treatment, hospitalization, etc.To address the perforation).

• Brand Name: ERBE APC 3
• Type of Device: ARGON PLASMA COAGULATOR
• 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: 15769903
• MDR Text Key: 303396265
• Report Number: 9610614-2022-00040
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K191234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APC 3
• Device Catalogue Number: 10135-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2020
• 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: 82 YR
• Patient Sex: Female