Model Number 101300 |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A facility reported that the carb-edge iris scissors (101300) was broken during use by the action of a small force.It was initially reported that the device was not in contact with the patient at the time it broke and was discovered broken after surgery.However, subsequent information was received reporting that the fracture occurred during the clamping in surgery.Reportedly, it took a while for staff to find a broken piece of instrument in the surgical site and a replacement instrument not already on the surgical set took time to prepare.An unspecified delay in surgery time occurred and the surgeon had to repeat the surgical procedure.To note, the apparatus was cleaned and disinfected according to prescribed protocol.The facility checked the cleaning, sterilization and management of the instrument, but no problems were found in the process.
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Event Description
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N/a.
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Manufacturer Narrative
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The suspected carb-edge iris scissors (101300) was not returned for evaluation, after three good faith efforts (gfe) to obtain the product.Lot number was provided, device history record (dhr) was reviewed and no abnormalities related to the reported issue were identified.The product lot number indicates a manufacture date of 2019.The issue of breaking during use may be the result of wear or environmental damage over time.However, a definitive root cause could not be determined.
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Manufacturer Narrative
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The carb-edge iris scissors (101300) was subsequently returned for evaluation: the carb-edge iris scissors was received in used condition with one of the tips broken off of due to rough handling/environmental damage.The product lot number indicates a manufacture date of 2019 and the sales order was sold in 2020, indicating damage may have occurred due to wear over two years of use.The reported complaint was confirmed.No manufacturing, workmanship or material deficiency has been identified.
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Search Alerts/Recalls
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