MAUDE Adverse Event Report: NEXTPHASE MEDICAL DEVICES LLC ERBE MODEL ECO2; ENDOSCOPIC CO2 INSUFFLATOR

Model Number ECO2

Device Problem Infusion or Flow Problem (2964)

Patient Problem Air Embolism (1697)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

The device was found to be functioning as intended the evaluation included an electrical safety check, a functional check of each of the equipment's features as well as flowrate output check.The device is within specification and all features are functioning properly.In addition, no anomalies were found in the device history record (dhr) of the involved device.In conclusion, no equipment problem was found that would have caused or contributed to the event.No determination could be made as to the cause of the event.Nevertheless, an embolism is a possibility when using an insufflator and there is a warning in the user manual addressing this type of situation ("procedural concerns - patient history and general procedure awareness is essential to overall procedure safety.Should accidental intravasation of co2 occur, in rare circumstances, it can result in embolism.").No trends have been identified and nextphase is closing the file on this event.

Event Description

It was reported that a patient incident occurred with the endoscopic co2 insufflator during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The unit's flowrate was set on medium.It was somewhat of a difficult cannulation.Eventually the bile duct was drained.At the tail end of the procedure, the patient became very hypotensive (i.E., low blood pressure) requiring the procedure to be aborted prematurely.The patient's skin mottled and he could not be extubated.Eventually, after going to the icu, he improved significantly and within a short period of time (less than 12 hours) which is why a co2 embolus is suspected.Please note, the nexcore gi insufflator model nx-350 is privately labeled for erbe usa, inc.As erbe model eco2.

• Brand Name: ERBE MODEL ECO2
• Type of Device: ENDOSCOPIC CO2 INSUFFLATOR
• Manufacturer (Section D): NEXTPHASE MEDICAL DEVICES LLC; 150 hopper avenue; waldwick NJ 07463 1513
• Manufacturer (Section G): NEXTPHASE MEDICAL DEVICES LLC; 150 hopper avenue; waldwick NJ 07463 1513
• Manufacturer Contact: salvatore rampaul-pino ; 150 hopper avenue; waldwick, NJ 07463-1513
• MDR Report Key: 11102576
• MDR Text Key: 229098119
• Report Number: 3002882053-2020-00001
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ECO2
• Device Catalogue Number: 7913-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2019
• 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): Hospitalization; Life Threatening
• Patient Age: 50 YR