AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE
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Model Number TB-0535FCS |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
Event Type
Injury
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Manufacturer Narrative
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This report is related to the following linked patient identifiers: (b)(6).The evaluation of the device is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported, the tips of two ultrasonic surgical devices broke in the middle of a therapeutic laparoscopic hysterectomy while the patient was under general anesthesia.The probe tip in one device was bent while the probe tip in the other device broke and the other end came off in the middle of the procedure.Reportedly, a part of the probe tip probably fell in the abdominal cavity, but this was not certain as the part was so small.The customer was unable to identify from which of the two devices it fell from.The part was not found, and no retrieval was done.The device also alerted the probe check and tests went through repeatedly until it was observed that the tips had broken down.The surgery time was extended by less than 30 minutes due to the repeated probe checks and retrieval of the new device.The procedure was completed with a similar device without any patient harm.This mdr is for the ultrasonic surgical device 1/2.
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Manufacturer Narrative
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This report is being supplemented to provide additional information from the customer.Please see updates to b2, b5, h6.The evaluation of the device is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported, the user tried to search for the detached part with the help of pliers but it was not found in the abdominal cavity.There was no imaging done at the decision of the gynecologist.
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Search Alerts/Recalls
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