Model Number B12SRT |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.
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Event Description
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It was reported that during a laparoscopic colectomy, the valve was broken off 10 minutes after the beginning of use.The broken valve and forceps fell outside the patient.The device was used on the colon.No pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.
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Manufacturer Narrative
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(b)(4).Date sent: 2/11/2020.Investigation summary: the analysis results found that the b12srt device was received with the valve of stopcock damaged.No functional test was performed due the condition of the device.In addition, a piece of plastic was returned inside of a plastic bag.It is possible that the damaged valve was due to improper handling of the device.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.
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Manufacturer Narrative
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(b)(4).Date sent: 1/17/2020.H2: additional information: the device was received for evaluation, however evaluation not yet begun.
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Search Alerts/Recalls
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