Model Number 8360-10 |
Device Problem
Break (1069)
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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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Preliminary investigation: as a result of an adverse trend for devices exhibiting failure at the thumb-loop assembly joint, a supplier corrective action request (scar) was initiated.The malfunction was evaluated by the supplier by looking at devices with a lot number beginning with "m." as a result of their findings, the push rod fixture was redesigned to increase the clearance, which ensured that the fixture appropriately stressed the entirety of the soldering joint.Upon implementing the new fixture, the supplier tested returned non-conforming samples, and verified that the soldering no longer hung up on the new fixture, as had been observed on the previous one.In addition to this scar, a corrective action/preventive action (capa) was opened by aesculap inc.For further evaluation of the design transfer of this device.Additional information / investigation results will be provided in a supplemental report, if available.
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Event Description
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It was reported to aesculap that a prestige atra grasper (part # 8360-10) device underwent a tug test in the sterile processing department (spd).According to the complainant, the proximal weld separated at the location of the handle.It was noted that device failed during the field safety tug test.The device was available to be returned to the manufacturer for evaluation.
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Event Description
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No updates.
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Manufacturer Narrative
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Manufacturer evaluation: aesculap inc.Previously reported that a supplier corrective action request (scar) was initiated due to an adverse trend observed for devices exhibiting failure at the thumb-loop assembly joint.The supplier evaluated the malfunction by looking at devices with a lot number beginning with "m." as a result of their findings, the push rod fixture was redesigned to increase the clearance, which ensured that the fixture appropriately stressed the entirety of the soldering joint.Upon implementing the new fixture, the supplier tested returned non-conforming samples, and verified that the soldering no longer hung up on the new fixture, as had been observed on the previous one.The complaint device was returned to the manufacturer for physical evaluation.A visual examination was performed which confirmed separation at the proximal weld.All returned non-conforming devices exhibited the same weld failure; a clean break occurred from the solder to the rotator housing.An investigation of the device manufacturing records was conducted by the manufacturer for the lot # of the device in question.No non-conformances were reported.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Additionally, historical scrap rates were reviewed with no increase observed in scrap related to the complaint issue.In addition to the redesign of the soldering fixture, the supplier reviewed the work instruction for the torch soldering operation and identified improvement opportunities.The original work instruction was used to better define the soldering process with a more focused emphasis on the following: equipment startup and shutoff operations, clear imagery of acceptable soldered subassemblies, and clarified cleaning operations for components prior to soldering.A second dedicated work instruction was implemented to better define the attribute inspection criteria for the brazing process used for the solder between the thumb loop and rotator block.The investigation into the cause of the reported problem was able to confirm the failure mode of a proximal weld failure.This event likely occurred due to inadequacies in the defined production process which limited the device performance.Therefore, the most probable root cause is considered to be manufacturing related.In addition to a supplier corrective action request (scar) being initiated, a corrective action/preventive action (capa) was opened by aesculap inc.For further evaluation of the design transfer of this device.
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Search Alerts/Recalls
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