MAUDE Adverse Event Report: GYRUS ACMI, INC PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK)

Model Number	920005PK
Medical Device Problem Codes	Defective Device (2588); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.This report will be supplemented accordingly following investigations.
Event or Problem Description
It was reported that the cutting forceps would not open upon using it for the first time.The issue occurred during a diagnostic procedure.The intended procedure was completed with a second like device.The lot/serial number used was not provided.There was no patient impact or harm 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, h6 and h10.The customer was contacted and has not provided the lot number for this device.Dhr (device history records) review could not be performed for the lot associated with this device.Since the device is not returning to olympus, no device evaluation could be performed.The complaint could not be fully confirmed due to the device not returning.However, since the complaint cannot be fully confirmed, the observed failure is a known phenomenon likely resulting from incorrect placement of the ratchet switch that controls the jaw open/close feature upon initial inspection of the device.On page 3 of the device ifu (instruction for use) (910111-001_ee), it states: the device is packaged in the ratchet off mode.When in the ratchet mode, the jaws will stay closed if the forceps grip is released.Olympus will continue to monitor the field performance of this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation, legal manufacturer's updated investigation and corrections to the report.The subject device has been received and completed evaluation.A visual inspection indicates that there is dried tissue on jaws consistent with use.The jaw symmetry is balanced.The first point of contact for the jaws is at the distal end; this is consistent with standard.The jaw aperture measurement could not be measured due to the jaws being stuck.The insulation of the jaw legs was inspected and found large cuts with two areas of exposed metal.The flare is in intact and has no cracks.The blade extends/retracts, but could not be tested with a dental dam as the jaws would not open.The lock function engages/releases as designed and the shaft is normal.The device was plugged into the test generator; the generator displayed vp3/35; this is the correct default setting.The base of the legs at the distal end are bent.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, the likely cause of the jaws stuck in the closed position is due to the bent legs at the distal end.The likely cause of the exposed metal from the damaged leg insulation may be due to mishandling.The observed failure is a known event resulting from applying excessive stress near the distal end of the device.The instructions for use (ifu) states: "if using the tip and shaft of the instrument to leverage tissue, ensure the jaws are closed to prevent deformation of the jaws." olympus will continue to monitor field performance for this device.

• Brand Name: PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK)
• Common Device Name: PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12025328
• Report Number: 3011050570-2021-00078
• Device Sequence Number: 17045203
• Product Code: GEI
• UDI-Device Identifier: 00821925036178
• UDI-Public: 00821925036178
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2021

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: 920005PK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 07/07/2021; 10/22/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/13/2021; 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1