MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. OLSEN MEDICAL; ELECTRODE

Model Number	20-1410IMT
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not able to be returned as it was discarded at the facility.The customer is unsure if the issue occurred due to the forceps or the cord used.The cord that was used is not an aspen/symmetry device.It was not confirmed if the cord that was used was an aspen/symmetry device.The dhr for the for the part lot combination was reviewed and found to have no non-conformances noted during the manufacturing process.Because the device will not be returned, the device cannot be tested to confirm the issue and determine a root cause.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 alleges, "one of the bipolar forceps olsen® midas touch 8-1/4 inch length non locking bayonet handle straight smooth insulated 1.5 mm tips was defective during surgery today.No output when the device was plugged in.No harm to the patient but a 10 minute delay occurred to get a new device.".

• Brand Name: OLSEN MEDICAL
• Common Device Name: ELECTRODE
• 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: 19397234
• Report Number: 3007208013-2024-00021
• Device Sequence Number: 12501585
• Product Code: GEI
• UDI-Device Identifier: 00841785104565
• UDI-Public: 00841785104565
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• 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: 20-1410IMT
• Device Lot Number: 134804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown