Beamer ESU CE200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04057607000106), received between Mar 7, 2017 and Mar 7, 2017 — classified as 1 death.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathMar 7, 2017Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY, ON (B)(6) 2017, THE SURGEON USED THE CE200 ELECTROSURGICAL UNIT (ESU) IN COMBINATION WITH ARGON BEAMER CB200 FOR TREATMENT OF EXTENSIVE ANGIODYSPLASIA OF THE RIGHT-SIDE COLON. THE PROCEDURE WAS COMPLETED AS PLANNED. THE PATIENT EXPERIENCED POST-OPERATIVE DISTENSION OF THE COLON AND A "PERFORATED BOWEL". THE SURGEON STATED THAT "HE BELIEVED THAT THE ESU CE200 ELECTROSURGICAL UNIT IN USE AT THE TIME, WAS SET ON THE CORRECT "ARGON RIGHT COLON 30W" SETTING." TO DATE NO FURTHER INFORMATION HAS BEEN RECEIVED REGARDING ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED FOR THIS REPORTED INJURY, NOR THE PATIENT'S CURRENT STATUS. ALL INFORMATION REGARDING THIS COMPLAINT HAS BEEN FORWARDED FROM THE MANUFACTURER'S DEALER IN (B)(4). THE REPORTED COMPLAINT ISSUE WAS EVALUATED BY THE MANUFACTURER'S COMPLAINT PROCEDURE. THE INVOLVED DEVICE WAS INVESTIGATED BY (B)(4) AND WAS FOUND TO LIE WITHIN ITS SPECIFICATION. THE REPORTED SETTINGS ARE OKAY AND WITHIN THE RECOMMENDED RANGE. IN THE PERFORMED PROCEDURE, A PERFORATION IS A KNOWN COMPLICATION.

  Patient problems: Abdominal Distention; Bowel Perforation

  MAUDE report 6384003 ↗