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

Model Number APC 2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bowel Perforation (2668)

Event Date 03/26/2021

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 (note: upon a review of the chronological data in the system, the settings may have been pulsed apc, effect 1, 40 watts, and 0.8 liters/minute.).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 reported incident.Specifically, upon the intervention work, 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.The account is being made aware of the findings.To further address the issue, additional in-service work was performed with the medical staff at their facility on 04/14/2021.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 300 d, part number (p/n) 10140-000, serial number (b)(4)) system was involved in a patient incident upon a colonoscopy.The equipment was used with an apc circumferential probe and the setting was "preset small bowel avm apc".The apc/esu system was used to ablate arteriovenous malformations (avms) in the small bowel.Per the account, there was nothing unusual during or after the procedure.Nevertheless, 24 hours later there was a perforation (note: no surgical intervention was needed to treat 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 ; 7709554400
• MDR Report Key: 11785398
• MDR Text Key: 249313804
• Report Number: 9610614-2021-00008
• 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: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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: 04/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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): Hospitalization
• Patient Age: 50 YR