GYRUS ACMI, INC. USA ELITE RIGID OPTICAL GRASPING FORCEPS; RIGID ENDOSCOPIC BIOPSY FORCEPS, REUSABLE
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Model Number E8215 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2023 |
Event Type
malfunction
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Event Description
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Customer reported the" grasper is not working, handle is not working".The reported issue found during an unknown event.There was no patient harm, no user injury reported due to the event.
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Manufacturer Narrative
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The subject device was received and evaluated.Device evaluation has confirmed the reported issue of "the grasper is not working, the handle is not working ".The issue was found to be due to jaw insert mechanism malfunctions.Damage found was noted to be beyond repair.Follow up is in progress to gather additional information regarding the reported event.To date, no response is received from the customer.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h4, h6 and h10.H4: based on the lot number the manufacturing date of the device was in the month of august 2015 but a specific date could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the damage occurred due to user mishandling along with excessive force that was applied to the device.The root cause of this event was unable to be identified.The following is included in the instructions for use: "excessive squeezing force on handles can lead to failure of forceps jaws." (page 6); and "prior to each use, inspect jaws/scissors blades and distal joints for any burrs, cracks, or rough edges.Do not use if any irregularities are present.Open and close handles to ensure smooth action." olympus will continue to monitor field performance for this device.
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