MAUDE Adverse Event Report: CONMED 7550 CONMED ELECTROSURGICAL GENERATOR & ABC MODES; ARGON GAS CAUTERY

Model Number 60-7550-120

Device Problem Insufficient Information (3190)

Patient Problem Bowel Perforation (2668)

Event Date 01/18/2021

Event Type  Injury  

Event Description

During colonoscopy, provider directed probe of argon gas cautery to ablate a non-bleeding angiodysplastic lesion when it appeared to push a burst of argon gas into the submucosal tissue in a "ripple effect" resulting in a perforation of the colon.

• Brand Name: 7550 CONMED ELECTROSURGICAL GENERATOR & ABC MODES
• Type of Device: ARGON GAS CAUTERY
• Manufacturer (Section D): CONMED
• MDR Report Key: 11308881
• MDR Text Key: 232352047
• Report Number: 11308881
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-7550-120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2021
• Distributor Facility Aware Date: 01/19/2021
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 76