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Model Number IPN915489 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2023 |
Event Type
malfunction
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Event Description
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It was reported that during testing, the blade cannot be removed from the handle anymore, it is stuck.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that during testing, the blade cannot be removed from the handle anymore, it is stuck.No patient involvement.
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Manufacturer Narrative
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(b)(4).The actual device was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "the customer returned one 133300 rusch greenled handle: medium for investigation.The handle was returned with a dahlhauseen blade 3 attached to it.The visual examination did not reveal any obvious defects or anomalies, as the handle device appears typical.The blade was stuck on the handle from the blade hinge, not from the steel ball side.The blade was able to be removed with ordinary effort.All edges of the returned blade and handle were examined, and it was noted that there were scratches observed on dahlhauseen blade 3 near the hinge (slot) profile.The functional inspection was performed per laryngoscope ifu by pushing downward on the fresh blade to release it from the handle, part of the instructions for use (ifu) were reviewed for this investigation.The handle device was functional tested with fresh blade by following the product guidelines.No problem found on customer returned handle device.The device history record for lot 23012701 was reviewed and no issue that could have contributed to the reported failure was noted.The device was ma nufactured according to release specification.The devices were tested 100% for functional testing prior to ship to customer." the complaint cannot be confirmed.The device was manufactured according to release specifications and tested 100% for functional testing prior to shipment to the customer.No problem was found with the returned handle.The device was found to be fully functional with different size fiber optic blades.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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