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 Burn (1756)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

After the incident, the hospital's technical team performed a safety inspection on the coagulator.According to hospital personnel, the apc was functional and safe.In addition, no anomalies were found in the device history record (dhr) of the apc.In conclusion, no erbe equipment problem was found that would have caused or attributed to the event.Based upon the information provided, it appears combustible gases (e.G., methane and/or hydrogen) were at such a concentration in the bowel that when diathermy was applied an explosion occurred.Although very rare the complication can occur.Therefore there is a warning in the erbe user manuals, "flammable endogenous gases in the gastrointestinal tract, risk of explosion to the patient!, extract the gases before performing electrosurgery or irrigate with co2".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) was involved in a patient incident.No information was provided in regards to the involved erbe esu or probe.Nevertheless, it was stated that an erbe apc/esu system was used in a sigmoidoscopy to stop rectal bleeding.Upon activating the coagulator, there was a loud bang in the bowel.Therefore, the endoscope with the probe were immediately withdrawn from the patient's bowel.A superficial burn occurred on the patient's rectal mucosa and no further information was provided in regards to the patient's condition.

• 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: 14110690
• MDR Text Key: 289251635
• Report Number: 9610614-2022-00009
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K024047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2022

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?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2019
• 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: 50 YR