APPLIED MEDICAL RESOURCES C4121, 45CM GRASPER REPOS CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
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Model Number C4121 |
Device Problems
Material Frayed (1262); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2023 |
Event Type
malfunction
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Event Description
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Procedure performed: laparoscopic roux-en-y.Event description: two similar complaints occurred at [user facility]: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).The surgeon used two graspers during "soft launch testing" and one of the devices experienced fraying at the tip of the latis pad.The surgeon noticed that the latis pad was fraying two hours into the three-hour procedure.The other device did not experience fraying or any other issues.They were able to finish the procedure normally.There was no impact to the case.No patient injury.The surgeon noted that they have seen this issue in the past but the device always performed as needed.Additional information was received via email on 23jun2023 from [name], clinical development analyst ii, applied medical: no, the user did not experience any tissue sticking or tearing when using the frayed device."the graspers were being used to handle tissue during a bariatric roux-en-y procedure.These tissues/organs interacted with include the stomach, small intestine, fat tissue (omentum and visceral fat), ligaments (gastrophrenic and gastrosplenic), and manipulation of the circular stapler anvil." harmonic energy device, circular stapler, linear stapler, laparoscopic graspers with teeth, monopolar pencil (l-hook), suction-irrigator, laparoscopic needle holders and [competitor] liver retractor were used during the procedure.Intervention: they were able to finish the procedure normally.There was no impact to the case.Patient status: no patient injury.
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Manufacturer Narrative
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The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a frayed latis pad.Based on the condition of the returned unit, the reported event likely occurred as a result of the use of the grasper.However, applied medical is unable to determine the exact root cause of the pad fraying based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
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Event Description
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Procedure performed: laparoscopic roux-en-y.Two similar complaints occurred at [user facility]: complaint 1 of 2: (b)(4) - c4121 lot #1472638 [mfr #2027111-2023-00528] complaint 2 of 2: (b)(4) [mfr #2027111-2023-00529].The surgeon used two graspers during "soft launch testing" and one of the devices experienced fraying at the tip of the latis pad.The surgeon noticed that the latis pad was fraying two hours into the three-hour procedure.The other device did not experience fraying or any other issues.They were able to finish the procedure normally.There was no impact to the case.No patient injury.The surgeon noted that they have seen this issue in the past but the device always performed as needed.Both devices used during the procedure are returning for complaint #(b)(4).[] additional information was received via email on 23jun2023 from [name], clinical development analyst ii, applied medical: no, the user did not experience any tissue sticking or tearing when using the frayed device."the graspers were being used to handle tissue during a bariatric roux-en-y procedure.These tissues/organs interacted with include the stomach, small intestine, fat tissue (omentum and visceral fat), ligaments (gastrophrenic and gastrosplenic), and manipulation of the circular stapler anvil." harmonic energy device, circular stapler, linear stapler, laparoscopic graspers with teeth, monopolar pencil (l-hook), suction-irrigator, laparoscopic needle holders and nathanson liver retractor were used during the procedure.Intervention: they were able to finish the procedure normally.There was no impact to the case.Patient status: no patient injury.
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Search Alerts/Recalls
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