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Model Number 8360-10 |
Device Problems
Break (1069); Solder Joint Fracture (2324)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an intraoperative issue with a prestige grasper.During a laparoscopic cholecystectomy procedure, the weld joint broke while the instrument was used for grasping.There was no patient harm or intervention required.There was an unspecified delay in surgery.Additional information was not provided.
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Manufacturer Narrative
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The malfunction has been investigated by the supplier, micro-stamping, and a corrective action (scar) was performed.Aesculap inc.Had opened a capa to follow this issue.Aesculap inc.Initially found that there was lack of flow of solder at weld, and broken soldering between the rotator housing and thumb loop.Micro-stamping evaluated multiple batch # starting with m.Micro-stamping re-designed the push rod fixture, increasing the clearance, to ensure that the fixture is appropriately stressing the entire soldering joint.Upon implementing the new fixture, it was verified that the new fixture does not hang up on the soldering as the old one did when testing a returned non-conforming sample.
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Event Description
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No update required.
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Manufacturer Narrative
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Additional information - d4 (udi), h4, h7 manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.However, based on prior evaluations of complaint devices reported with a failure mode of distal/proximal weld failure/separation, this event likely occurred due to inadequacies in the defined production process which limited the device performance.Aesculap inc.Opened a corrective action/preventive action (capa) for further evaluation of the design transfer of this device.
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Search Alerts/Recalls
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