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

Model Number ECO2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 12/31/2020

Event Type  Death  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Therefore, no determination could be made as to the root cause of the event.Nextphase is closing the file on this event.

Event Description

Per oral endoscopic myotomy was performed on patient.Patient has a history of cardiac issues.Posterior approach failed poem previously and therefore anterior approach was taken.Due to prior treatment, severe fibrosis was encountered.During the retrograde myotomy, patient experienced cardiac issues.Immediate response by trauma team ensued, patient was deemed brain dead shortly after and after 11 day stay in icu expired.Staff does not need equipment evaluated, stated there was no issue with the performance of equipment used.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 ; 2019689400
• MDR Report Key: 11495038
• MDR Text Key: 240062704
• Report Number: 3002882053-2021-00001
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2019
• 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): Death
• Patient Age: 64 YR