MAUDE Adverse Event Report: GYRUS ACMI, INC CUT/FCP,5MM/33CM DES III (5/PK); BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS

Model Number	3006
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated.Visual inspection noted that the device was received with the jaws closed, lock off.Initial inspection observed that the jaws slowly opened due to restriction likely caused by the foreign residue located on the jaws.Dried tissue on jaws observed and consistent with use.The jaw symmetry is balanced, no visual damage noted.The first point of contact for the jaws is at the distal end; this is consistent with standard.The jaw aperture measurement was taken inside the first teeth of the jaw, measured at.325", (standard is.300¿ +/-.100¿).The jaw mesh is normal.The insulation of the jaw legs was inspected and found scrapes and two areas of exposed metal.The flare was observed to be intact and found no cracks.Testing of the blade extends/retracts and blade was able to extends/retracts and cut without any issue.The lock function engages/releases as designed and the shaft is normal.Testing verified that when the ratchet switch was turned to on and the forceps grip was fully grasped the forceps jaws was able to lock properly until the release trigger is pressed.Action test was performed over 50 times continuously, the ratchet switch to off and fully grasped the forceps grip at least 50 times continuously and verified that the forceps jaws was not locking by itself which indicates the device is working properly.Additionally, the customer's 3006 forceps with a test esg-400 pk technology along with a test foot switch were tested.The settings were adjusted, verified that the 3006 was working properly.Based on evaluation findings the reported issue was unable to duplicate.The locking mechanism was working properly as it was tested several times and no issues were found.Unrelated to the reported issue, further testing found device insulation was found with a crack exposing metal.The cause of the locking mechanism not working could likely be attributed to the foreign residue on the distal end.The cause of the crack is unknown.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that during an unspecified procedure the device failed.The locking mechanism was not working.The intended procedure was completed using another device (same model).There was no patient harm or injury reported on this event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.The following sections were updated: d8, g3, g6, h2, h4, h6, and h10.After evaluation by olympus, the cause of the locking mechanism not working properly could likely be attributed to the foreign residue observed on the distal end.The insulation of the jaw legs was inspected and found scrapes and two areas of exposed metal.This insulation defect is most likely due to user mishandling.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.

• Brand Name: CUT/FCP,5MM/33CM DES III (5/PK)
• Common Device Name: BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11367022
• Report Number: 3011050570-2021-00045
• Device Sequence Number: 19799771
• Product Code: GEI
• UDI-Device Identifier: 00821925035898
• UDI-Public: 00821925035898
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K023492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 3006
• Device Lot Number: FR101627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1