Model Number FB411R |
Device Problem
Human-Device Interface Problem (2949)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2023 |
Event Type
malfunction
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Event Description
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It was reported that there was an issue with fb411r - de'bakey atr.Fcps 1.5mm str150mm.According to the complaint description, the device once tore tissue during a hernia procedure.It was noted that the "teeth" did not approximate correctly.A temporary impairment occurred; there was no further patient harm nor surgical delay.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Manufacturer Narrative
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Investigation: the instruments were tested according to qstd.The test material (silk paper) is not damaged when the tweezers are closed evenly.The inner sides of the jaw tips are rounded according to the specifications and do not hook into the skin during the tactile test.The jaw closes resiliently from the jaw tip over the entire interlocking tooth profile.Device history record: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products were found to be according to our specification valid at the time of production.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Explanation and rationale/conclusion: no deviations from the specifications valid at the time of production could be ascertained.Maybe twisting of the forceps legs may have led to tearing of the tissue.No product related failure could be detected.Based upon the investigation results, a capa is not required.
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Search Alerts/Recalls
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