MAUDE Adverse Event Report: GYRUS ACMI, INC PK SPATULA

Model Number	PK-SP0533
Medical Device Problem Codes	Break (1069); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was evaluated.Visual inspection on the received condition was performed and noted a piece of the ceramic tip broken off and was observed to be missing.The missing piece was not returned for evaluation.Evaluation of the device estimated that approximately 10 percent of the ceramic piece was missing at the distal end.Additionally, the metals have become separated at the distal end.The buttons, cable, handle, nosecone, and shaft all appeared to be normal.The distal end has reddish foreign material, which is consistent with use.Further, the device was functionally tested by connecting the cable from the complaint device to the esg-400 generator, which was then powered on.The settings on the generator were set to default.There were no error codes displayed.Functional testing on the device was performed.Testing confirmed that the coagulation (blue button) and cut (yellow button) both function as intended.Based on the evaluation, the customers reported complaint of error code message was not able to be duplicated, however, the ceramic portion of the distal tip was found broken and the metal at the distal tip was observed separating.Investigation is ongoing.This report will be supplemented accordingly following investigations.
Event or Problem Description
It was reported that during an unspecified procedure, the device when connected to the generator exhibited an error message.According to the report, the error message received was similar to the one where the user have to clean the tip of the device but did not engage on the tissue yet.The user tried to unplug and plug back and reboot the system however the issue was not resolved.The type of error message received was not provided.The device was replaced with similar device from the same lot and the intended procedure was completed.There was no patient harm or impact reported due to the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2,h4,h6 and h10.The dhrs (device history records) for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Based on the device evaluation, it was unable to replicate the user's complaint of "error codes".However, the ceramic portion of the distal tip has broken off, and the metal at the distal tip is separating which is likely due to mishandling.The observed failure is a known phenomenon resulting from mishandling and possible loose connections/incoherence between the device and generator settings.On page 6 of the device ifu (instruction for use) it states: ensure that the instrument plug is fully seated in the esg-400 generator socket before use.Also: "interference produced by the operation of high-frequency surgical equipment may influence the operation of other electrical equipment adversely.Refer to the generator instructions for use" olympus will continue to monitor complaints for this device.

• Brand Name: PK SPATULA
• Common Device Name: PK SPATULA
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12305180
• Report Number: 3011050570-2021-00091
• Device Sequence Number: 11837746
• Product Code: GEI
• UDI-Device Identifier: 00821925041806
• UDI-Public: 00821925041806
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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 Model Number: PK-SP0533
• Device Lot Number: FR145195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR