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 01/26/2023

Event Type  Injury  

Manufacturer Narrative

The apc/esu system with it footswitch were returned and thoroughly inspected/tested.The findings were as follows: apc: a technical safety check was performed on the unit.This included an electrical safety check, a functional check of the equipment's features, and a power output check.All features were/are functioning properly within specifications.Also, the gas flow rates were measured and found to be within their acceptable ranges.In addition, no anomalies were found in the device history record (dhr).In conclusion, no equipment problem was found that would have caused or attributed to the event (note: unrelated to the reported issue, the unit's software was updated.).Esu: no issues were found with the unit that would have caused or contributed to the reported patient incident.The evaluation included an electrical safety check, a function check of each of the equipment's features, and a power output check.All features were/are functioning properly within specifications.In addition, no anomalies were found in the device history record (dhr) of the involved device.However, the esu needed servicing (i.E., a monopolar socket that is not involved with apc was worn and numerous error codes were found in the unit's error log over the last year); but it was not serviced due to its age (note: the model software version is obsolete.).Vio double foot pedal with remode (part number 20189-105 and lot number zv-zv) the accessory was found to be functioning properly.However, its cable was worn and needed to be replaced.Most likely, there were many factors involved in the reported incident.The desired setting may not haven selected/used, etc.However, the patient being elderly, a very thin-walled area needed to be treated, etc.Were key patient factors in the event.Nevertheless, upon the interventional work, the remaining tissue of the bowel did not stay intact which resulted in the perforation.Finally, no conclusive determination could be made as to the cause of the incident.To further address the issue, additional in-service work will be offered to the staff at the medical center.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) [model vio 300 d, part number (p/n) 10140-000, serial number (b)(4)] system was involved in a patient incident.The apc/esu system with an apc circumferential probe was used in a colonoscopy.Upon argon plasma coagulation, a perforation occurred in the cecum.Therefore, surgery was performed to repair the perforation.

• Brand Name: ERBE APC 2
• 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: 16598523
• MDR Text Key: 311849353
• Report Number: 9610614-2023-00020
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• 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: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2004
• 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: 65 YR
• Patient Sex: Female