It was reported that a patient underwent an unknown procedure with a reprocessed harmonic ace+7 shears with advanced hemostasis.The device was used off label on a metal uterine manipulator and the blade fractured and was unusable.The returned device was examined.The device serial number is (b)(6) which links it to lot 2131872.There is no observed structural damage to the housing or shaft of the device.It was observed that the jaw, the hinge, the tissue pad and the cutting rod were covered in eschar and dried biological contaminants; indicative of patient contact and multiple sealings.The tissue pad appears in proper position, whole and intact.The metal blade was broken in twain.The detached piece was examined under magnification.There are observed scratches and gouging in spots on the detached piece.The broken edge was jagged and not smooth.This confirms the reported issue.The appearance of this damage is indicative of contact with other metal during use, as is noted in the report from the account that the device improperly made contact with the metal section of a uterine manipulator (a surgical instrument) during the procedure, resulting in a broken blade.Per the instructions for use, reprocessed harmonic ace® +7 shears with ah: "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." and "caution: scratches on the blade may lead to premature blade failure.Avoid accidental contact with other instruments during use.¿ it was plugged into generator g11.The generator noted it was identifying the device, but then displayed the message "no instrument uses remaining".The device was disconnected and re-attached, and it resulted in the same display.Device has been used and has reached its end of life.The device history record for lot 2131872 was reviewed, and the device passed all visual and functional criteria prior to being distributed to the customer.A manufacturing record evaluation was conducted as there were no identified nonconformances.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
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