MAUDE Adverse Event Report: CONMED CORPORATION; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	130187
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed 10fr suction bovie piece of plastic broke off completely and was temporarily lost.Repeat bronch and confirmed that no plastic was left in the patient¿s airway.The piece was later found in the suction line.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 18501832
• Report Number: 18501832
• Device Sequence Number: 20854931
• Product Code: GEI
• UDI-Device Identifier: 30653405059930
• UDI-Public: (01)30653405059930(17)270804(10)202208059
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/14/2023
• Report Date (Section F): 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 130187
• Device Catalogue Number: 130187
• Device Lot Number: 202208059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/09/2024