MAUDE Adverse Event Report: OLSEN MEDICAL CORP OLSEN; BIPOLAR FORCEPS

Model Number	90-8012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been no further information provided since the initial complaint notification.We will continue to follow up with the customer for more information.A follow up report will be submitted once we have additional information.
Event or Problem Description
The customer alleged that they are receiving complaints from our neurosurgeons regarding the non-stick bipolar forceps getting stuck in the brain tumor tissue during surgery, leading to the use of micro scissors to seperate the tissue from the bipolar.There has been no patient harm.
Additional Manufacturer Narrative
After mutliple attempts to have the device returned and gather additional information, the device was not returned and not enough information was provided to determine a true root cause.There has been a total of (b)(4) sold of all lots with one additional complaint recorded that occurred in 2017 for a similar occurrence.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.

• Brand Name: OLSEN
• Common Device Name: BIPOLAR FORCEPS
• Manufacturer (Section D): OLSEN MEDICAL CORP; 3230 commerce center place; louisville KY 40211
• Manufacturer (Section G): OLSEN MEDICAL CORP; 3230 commerce center place; louisville KY 40211
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 16099369
• Report Number: 3000719969-2023-00001
• Device Sequence Number: 15081010
• Product Code: GEI
• UDI-Device Identifier: 00841785110405
• UDI-Public: 00841785110405
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K982705
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 90-8012
• Device Catalogue Number: 90-8012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown