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 03/27/2019

Event Type  Injury  

Manufacturer Narrative

The apc/esu system was returned and thoroughly inspected/tested.The findings were as follows: apc: unrelated to the reported erroring, the coagulator intermittently errored (i.E., registered error code a-12 messages).Therefore, an alignment (i.E., a calibration) was performed on the apc, which resolved the erroring.After the calibration, a technical safety check was performed on the unit to confirm that all features are functioning properly.The coagulator was calibrated and meets specifications.Esu: inspection/testing revealed that the motherboard printed circuit board (pcb) was the cause of the reported erroring messages.No determination was made as to what caused the pcb's nonconformance.Nevertheless, the board was replaced and the erroring ceased.After the repair, an alignment (i.E., a calibration) was performed on the esu to ensure that all parameters are within specifications.Then a two (2) hour burn-in stress test was completed on the unit to verify system stability.Finally, a technical safety check was performed on the generator to confirm that all features are functioning properly.The esu was calibrated, functioned well under stress, and meets specifications.No equipment problem was found that would have caused or contributed to the reported patient event (i.E., the erroring messages were unrelated to the patient incident.).In addition, no anomalies were found in the device history records (dhrs) of the involved devices.Most likely, there were many factors involved in the reported event.However, the patient's condition was a key factor in the outcome.That is, having ulcerative colitis with the need for treatment in the cecum (i.E., control of bleeding in a very thin-walled area of the bowel).Specifically, upon argon plasma coagulation (the intervention work), the remaining tissue of the bowl did not stay intact which resulted in the delayed 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 is being offered to the medical staff.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 300 d, part number (p/n) 10140-100, serial number (b)(4)) was involved in a patient incident.Initially, the account reported that the apc/esu system was erroring (i.E., registering error code c-30-a messages in the forced apc mode) and then reported that a patient event occurred.The system was used with a straight fire probe in a colonoscopy to treat bleeding in the cecum on a patient with ulcerative colitis.Pulsed apc and forced apc modes were used in the intervention work.Upon argon plasma coagulation, a perforation occurred.To address the issue, a partial colectomy was performed on the patient the next day.

• Brand Name: ERBE APC 2
• Type of Device: ARGON PLASMA COAGULATOR
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse; GM
• Manufacturer (Section G): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse; GM
• Manufacturer Contact: john tartal ; 2225 northwest parkway; marietta, GA 30067-9317
• MDR Report Key: 8561260
• MDR Text Key: 143431070
• Report Number: 9610614-2019-00011
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 04/15/2019
• Is the Reporter a Health Professional?: Yes
• Device Age: 5 YR
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2013
• 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: 50 YR