MAUDE Adverse Event Report: CONMED CORP CONMED BEAMER PLUS ESU; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number CE 200

Device Problem Overheating of Device (1437)

Patient Problem No Code Available (3191)

Event Date 01/08/2020

Event Type  Injury  

Event Description

The patient underwent a colonoscopy under moderate conscious sedation.The patient was noted to have a tortuous colon.The setting of the conmed beamer was thought to be on "snare/hot biopsy polypectomy right colon" which had been programmed and used by providers during the training by the conmed representative.After completing the polypectomy, the surgeon noted an area of char at the site and four hemostatic clips were placed on the tissue to prevent bleeding.The patient was discharged after the procedure but required an office visit and closer monitoring.The setting was noted to be on the right colon dual mode which had not been activated/programmed.The conmed was contracted and promptly arrived to check that all of the nine conmed beamers had been properly programmed as requested.

• Brand Name: CONMED BEAMER PLUS ESU
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORP; utica NY
• MDR Report Key: 9971942
• MDR Text Key: 188390749
• Report Number: MW5094177
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/16/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CE 200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 52