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Catalog Number R1945 |
Device Problem
Failure to Eject (4010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 when used, the bar of the ruggles gardner-wells traction tongs - stainless (r1945) did not drop and caused the tongs to become stuck in the patients head.The tongs were so stuck in the patients head it took great force to unscrew the tongs and remove from the patients head.No adverse impact to the patient was reported, neither delay in surgery.
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Manufacturer Narrative
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The ruggles r1945 was returned for evaluation: failure analysis: the returned r1945 is in used condition with the pins stuck in position and unable to be adjusted by hand.Pin threading had damage due to rough handling/environmental damage, preventing proper adjustment.The retractor hook was disconnected from the unit.Root cause: the reported complaint is confirmed.The returned r1945 ruggles gardner-wells traction tongs is in used condition with the pins stuck in place due to damage to the threading.No manufacturing, workmanship, or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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Search Alerts/Recalls
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