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 03/12/2020

Event Type  Injury  

Manufacturer Narrative

The apc/esu system was returned and thoroughly inspected/tested (note: the accessories were not available for an evaluation.).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.Note: our review of the chronological data revealed that the system was not used on march 12th when according to the hospital the intervention work took place.Most likely, there were many factors involved in the reported incident.However, the patient's condition in all likelihood was a key factor in the outcome.That is, having to perform argon plasma coagulation in the right colon, a very thin-walled area of the bowel.Specifically, upon the intervention, 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.Note: if an arc arises between the active electrode and tissue, low-frequency current can occur which may have caused the reported muscle twitching which is known in the literature as neuromuscular stimulation and also described in the safety instructions of the user manuals.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) with an electrosurgical unit (esu/generator, model vio 200 d, part number (p/n) 10140-200, serial number (b)(4)) was involved in a patient incident.The system was used with an apc probe (p/n 20132-225, lot number 143887) and a split return electrode (p/n 9160 f, lot number unknown).During intervention work in the cecum (also referred to as the right colon).During each activation, the patient twitched.The next day, a perforation was detected in the cecum.To address the issue, an operation was performed on the patient.Note: system distributed to a hospital in (b)(6).

• 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
• MDR Report Key: 9876768
• MDR Text Key: 195289329
• Report Number: 9610614-2020-00007
• 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: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2020

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: 03/17/2020
• Device Age: 3 YR
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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; Required Intervention
• Patient Age: 76 YR