MAUDE Adverse Event Report: CONMED CORPORATION ABC BEND-A-BEAM; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number 134003

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

Event Description

During a procedure, the argon beam hand piece would not work.After trouble-shooting the machine itself, staff noted that the issue was likely the handpiece.Staff opened a new hand piece and had no further issues.The defective hand piece was removed from the field and given to material's management to coordinate with the manufacturing representative.No harm came to the patient and there were minimal delays to the procedure.

• Brand Name: ABC BEND-A-BEAM
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 10816041
• MDR Text Key: 215514116
• Report Number: 10816041
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2020

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
• Device Operator: Health Professional
• Device Model Number: 134003
• Device Catalogue Number: 134003
• Device Lot Number: 202008314
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 138