MAUDE Adverse Event Report: OLSEN MEDICAL LLC SYMMETRY OLSEN; JEWLERS BIPOLAR FORCEPS

Model Number	20-1060KI
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.It will be sent to our manufacturing facility to confirm that it was properly manufactured.There has been a total of (b)(4) sold of all lots of this product code with no additional complaints recorded for this occurence.A follow up report will be submitted once we have completed our investigation.User facility report (b)(4).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 at the beginning of the procedure, it was discovered that the tips of the disposable bipolars crossed.Per the doctor, this is becoming more common.When using the bipolar forceps and the tips cross, there is an increased risk for damage to the surrounding tissues and other surgical complications.
Additional Manufacturer Narrative
The device was evaluated by the manufacturing location.It was confirmed that the tips would cross when pressure was applied to the forceps.This particular device is more susceptible to being misaligned due to the very small tip size (0.4mm).The smaller tips require more precise alignment of the tips due to the small surface area of contact point compared to other devices.These devices are received as a sub assembly from the supplier.The supplier performs the alignment check to ensure there is no misalignment or crossing of the tips during manufacturing.There is no alignment check at the louisville manufacturing location.It is unknown when the misalignment occurred.However, as a precaution, the supplier was notified of the misalignment.No further actions are required per the risk assessment of this complaint.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the 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.

• Brand Name: SYMMETRY OLSEN
• Common Device Name: JEWLERS BIPOLAR FORCEPS
• Manufacturer (Section D): OLSEN MEDICAL LLC; 3230 commerce center pl; louisville KY 40211
• Manufacturer (Section G): OLSEN MEDICAL LLC; 3230 commerce center place; louisville KY 40211
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 13538627
• Report Number: 3000719969-2021-00004
• Device Sequence Number: 14520968
• Product Code: GEI
• UDI-Device Identifier: 00841785102813
• UDI-Public: 00841785102813
• 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,Followup
• Report Date (Section B): 01/13/2022

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: 07/28/2026
• Device Model Number: 20-1060KI
• Device Catalogue Number: 20-1060KI
• Device Lot Number: 121864
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• 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