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 10/09/2019 |
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 issue with prestige graspers.The graspers were broken at the weld.The faciliity noted that this puts a strain on remaining instrument sets.There was no patient harm or intervention required.The incident occurred in surgery (to be confirmed).Additional information was not provided.Associated medwatches: 5 instruments reported separately.
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Manufacturer Narrative
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Several complaints and mdrs had been created due to the original reported issue; 3 cases were closed as duplicates, and 2 mdr follow-ups will be submitted with clarification.Originally reported malfunction: broken at weld.
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Event Description
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Clarification was received: sales consultant confirmed that all graspers were noted to be malfunctioning in sterile processing - that there was no patient involvement.
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Manufacturer Narrative
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B5: update.The malfunction has been reported to the supplier, smith & nephew.Associated medwatches: 400448614 (2916714-2019-00110); 400450717 ( 2916714-2019-00111); 400450718 ( 2916714-2019-00112)- duplicate; 400450719 ( 2916714-2019-00113) -duplicate; 400450725 (2916714-2019-00114) -duplicate.
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Event Description
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Clarification: the reported malfunction, weld broken, was found to have occurred in sterile processing and not in a surgery.
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Manufacturer Narrative
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Additional information - d4 (udi), 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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Event Description
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No update required.
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Search Alerts/Recalls
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