MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. BOVIE MEDICAL; CAUTERY

Model Number	AA01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was able to be confirmed from pictures from the customer.According to the end user, they were 5 seconds into the activation of the device when the tip broke.Root cause is determined to be user error in using the device for a different intended use, and an extended activation time.According to the attached ifu, - applying excessive force on the cautery during use may cause tip to bend or break.- the recommended duty cycle is 2 seconds on and 6 seconds off for a continuous time of no longer than 15 minutes - intended use - bovie® cautery devices are used for stopping small bleeders in hemostasis and other similar uses.If additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.Until such time, this can be seen as the final report.
Event or Problem Description
The complainant alleged, "the tip broke off during use.No patient consequence, however it was noted that the surgery was canceled.".

• Brand Name: BOVIE MEDICAL
• Common Device Name: CAUTERY
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 19393538
• Report Number: 3007208013-2024-00022
• Device Sequence Number: 12456557
• Product Code: HQP
• UDI-Device Identifier: 00607151011017
• UDI-Public: 00607151011017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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
• Device Model Number: AA01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown