MAUDE Adverse Event Report: GYRUS ACMI, INC HALO PKS CUTTING FORCEPS,5MM/33CM

Model Number HACF0533

Device Problems Device Stops Intermittently (1599); Intermittent Energy Output (4025)

Patient Problem Injury (2348)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation at the time of this report and no conclusion can be determined at this time.If additional information or if the device is received at a later time a supplemental report will be submitted.

Event Description

Olympus received an adverse incident report from (b)(4), which stated that "forceps working intermittently and someone has been harmed.".

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation findings, to provide the device code and to update sections.The device was returned to olympus for evaluation.The customer¿s complaint of intermittent function was confirmed.A visual inspection was performed on the received device and found that the device jaws were open and in the ¿latch on¿ position.The jaw aperture was found to be in specification and measured at approx.0.283 inches.The jaw mesh appeared abnormal as that jaws were bent towards the tip and the teeth do not mesh in the back.The heat shrink was found split near the bend in the leg and bare metal was exposed.It appears no material is missing.No further physical damage noted during physical inspection.The latch operates as intended, jaws rotate and the blade extends and retracts smoothly.Dome switches actuate when pressed from various locations.During functional testing, the g400 generator recognizes the device as halo and sets default settings appropriately (vp3/35).Testing was complete on a range of beef tissue thicknesses.On full-bite, thick tissue samples, the device functioned as intended.Several regrasp errors were observed when testing on thin beef tissue.Due to the thickness of this tissue it is possible that the jaw teeth came in contact with one another, shorting the connection and therefore the regrasp error was warranted and was triggered as designed.Teeth are more likely to break through when the jaws are bent and additional pressure is being placed on the already thin tissue.Based on the device evaluation, it is likely the bent jaws caused by pressure led to the regrasp errors occurring at a greater frequency than expected on thin tissue.The instruction manual wars users" do not activate the device while adjacent to or in contact with other metallic objects or devices.Unintended tissue injury and/or damage to the contacted object or device may occur.".

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The dhr 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.

• Brand Name: HALO PKS CUTTING FORCEPS,5MM/33CM
• Type of Device: CUTTING FORCEPS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 7640380
• MDR Text Key: 112417748
• Report Number: 2951238-2018-00374
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K100896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HACF0533
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other