Model Number EL5ML |
Device Problems
Break (1069); Detachment of Device or Device Component (2907); Device Fell (4014)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformance's were identified.Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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It was reported that during a gyn procedure, one of jaws on the tip of device broke off and fell into the patient.The piece was visually located and removed from the patient.It is unknown how the procedure was completed and there were no patient consequences reported.
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Manufacturer Narrative
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(b)(4).D4: batch # t93r7y.Investigation summary: the analysis results found that the el5ml device was received with the jaw broken.No functional test was performed due the condition of the device.The device was disassembled and 7 clips were found inside the clip track.It is possible that the damage to the device occurred 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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Search Alerts/Recalls
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