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Model Number HAR36 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/07/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint device was returned to stryker sustainability solutions for evaluation.Inspection of the returned device revealed evidence of clinical use and an indention in the teflon pad.Visual inspection confirmed that the distal tip of the blade was broken off.A review of the device history records supports that the device was unlikely to have been released from stryker with the reported failure mode.Therefore, the most likely root cause of the broken blade is incidental or prolonged activation against solid surfaces, such as bone, metal or plastic.The instructions for use state: "avoid contact with any and all metal or plastic instruments or objects when the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.".
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Event Description
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It was reported that during a hysterectomy, the blade broke in the patient.The tip came off into the patient and it was broken in half.The tip was retrieved laparoscopically.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
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Search Alerts/Recalls
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