MAUDE Adverse Event Report: OLSEN MEDICAL LLC SYMMETRY OLSEN; JEWELERS BIPOLAR FORCEP

Model Number	20-1060KI-28
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer made reference to an fda report regarding this incident on 11/12/2021.We have not received a copy of this report to date.Upon receiving the device for evaluation, it was tested for proper functionality.The device functioned as intended and was found to be within conformance per the product specifications.If the tips of the device were touching when the device was plugged into the generator and activated, arcing of the tips would occur.This arcing would explain the pop that they heard upon activation.The dhr for this lot number was reviewed and it was confirmed that all items within this lot were within conformance per the product specifications prior to shipping.There has been a total of (b)(4) sold of all lots with no additional complaints recorded for this occurrence.This is an isolated event.Based on the above information, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.This submission is passed due as we recently discovered that the original submission was not accepted due to an old version of esubmitter.
Event or Problem Description
The customer alleged that the tips of the forceps popped when they were plugged into the generator and activated.There was no harm to the patient as a result.

• Brand Name: SYMMETRY OLSEN
• Common Device Name: JEWELERS BIPOLAR FORCEP
• Manufacturer (Section D): OLSEN MEDICAL LLC; 3230 commerce center pl; louisville KY 40211
• Manufacturer (Section G): OLSEN MEDICAL LLC; 3230 commerce center pl; louisville KY 40211
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 13544889
• Report Number: 3000719969-2021-00003
• Device Sequence Number: 4271291
• Product Code: GEI
• UDI-Device Identifier: 00841785102820
• UDI-Public: 00841785102820
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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 Expiration Date: 07/28/2025
• Device Model Number: 20-1060KI-28
• Device Catalogue Number: 20-1060KI-28
• Device Lot Number: 118021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2020
• 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