MAUDE Adverse Event Report: SYMMETRY SURGICAL INC MCKESSON; HIGH TEMP CAUTERY

Model Number	244
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer discarded the device involved.The customer was unsure if it was lot# 0322z or 0622z.They returned additional samples of both lot numbers for evaluation.Customer activated the device for 5 seconds and left inactive for 20 seconds to several minutes.Product was received through the rma room on (b)(6) 2023.Product was tested in accordance with vp-0147 to find the voltage and the correlation to the temperature at the tip upon activation.3 of each lot for voltage at the brass poles: lot 0322z 1.765 v = 2203f.1.887 v = 2290f.1.767 v = 2205f.Lot 0622z.1.647 v = 2120f.1.969 v = 2348f.1.982 v = 2357f.Per design, high temperature cauterys are intended to reach temperatures in a range of 200f-2400f at the initial activation.All products returned and tested for voltage at the tips passed this specification.Products were also tested per customer use/activation timing to see if the event could be recreated.4 new cauterys from the returned devices, 2 from each lot, were selected and activated for 5 seconds at a time.None of the devices caused the tip to burst while activated for extended period of time (5 seconds minimum).Per attached ifu, mc-23234 it is recommended to activate the device for 2 seconds on, followed by 6 seconds off when using the device for no more than 15 minutes.(duty cycle) complaint was unable to be confirmed.Root cause is believed to be user error in activating the device for an extended period of time, outside the directions listed in the ifu.This is the first complaint recorded for this occurrence with 66,030 sold of all lots.Based on the above information, no further actions are required.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information pertinent to the investigation, a follow up report will be submitted.
Event or Problem Description
The customer alleged that the cautery tip came off and burned a patient.There was no significant harm to the patient.

• Brand Name: MCKESSON
• Common Device Name: HIGH TEMP 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: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 16639208
• Report Number: 3007208013-2023-00015
• Device Sequence Number: 6379447
• Product Code: GEI
• UDI-Device Identifier: 20612479209071
• UDI-Public: 20612479209071
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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: 244
• Device Catalogue Number: 244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown