MAUDE Adverse Event Report: GYRUS ACMI L.P. PK SPATULA

Model Number	PK-SP0533
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an out of box failure on her olympus pk spatula.According to the initial reporter, the unit activated on its own.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.
Additional Manufacturer Narrative
The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Event or Problem Description
Additional event info.Received: the procedure was a therapeutic total laparoscopic hysterectomy and completed using another spatula device without impact to the patient.
Additional Manufacturer Narrative
Updated: d4 lot number, b5, d4 lot number, d9, d10, h3, h4, h6, h10.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it was found that the device cut and coag (coagulation) buttons failed to function/activate the device unless the footswitch was connected; with the footswitch connected, the cut and coag buttons activated the device and functioned as intended.The root cause of the device cut and coag switch failure could not be determined.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Correction: d3, g1, h11 this report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: PK SPATULA
• Common Device Name: SPATULA
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18003118
• Report Number: 3003790304-2023-00409
• Device Sequence Number: 7677822
• Product Code: GEI
• UDI-Device Identifier: 00821925041806
• UDI-Public: 00821925041806
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: PK-SP0533
• Device Lot Number: FR235618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 02/27/2024; 06/19/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 02/29/2024; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS POWERSEAL
• Patient Sex: Unknown