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Model Number 212186 |
Device Problem
Contamination of Device Ingredient or Reagent (2901)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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This pi is for case 3 of 3.All case day the scrub nurse reported a grey greasy substance rubbing off onto gloves from the attachment pieces.We have three complete sets and all sets had to be re-run and flashed all day and still came up with the grey grease.The scrub nurse did not want to accept this onto the back table as no one could definitively state whether or not it was sterile.The or manager is wondering a couple things.One, is this happening at other accounts? if so, how are they navigating this? two, is there anything in writing that states that when this does occur, it is sterile and okay to proceed with the case? according the manager, if there was something in writing the scrub nurse and techs wouldn¿t be able to refuse taking the attachments at their own discretion.Looking for some direction for the management and sterilization department.Update on (b)(6) 2019 wg: as reported by rep: "this has probably happened in all three tka cases that day.The patients were in the room but not quite completely under.Not sure how you would consider that in terms of being ¿under anesthesia¿ as they only really do spinals at this hospital.The solution hasn¿t been resolved.They are waiting for official word, but as for now if they continue to come up with the grease or gray stuff they are deeming them unsterile and rejecting them.The procedure was completed successfully.I do not need replacements unless you deem it necessary." case type unknown.
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Event Description
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This pi is for case 3 of 3.All case day the scrub nurse reported a grey greasy substance rubbing off onto gloves from the attachment pieces.We have three complete sets and all sets had to be re-run and flashed all day and still came up with the grey grease.The scrub nurse did not want to accept this onto the back table as no one could definitively state whether or not it was sterile.The or manager is wondering a couple things.One, is this happening at other accounts? if so, how are they navigating this? two, is there anything in writing that states that when this does occur, it is sterile and okay to proceed with the case? according the manager, if there was something in writing the scrub nurse and techs wouldn¿t be able to refuse taking the attachments at their own discretion.Looking for some direction for the management and sterilization department.Update 12/november/2019 (b)(6): as reported by rep: "this has probably happened in all three tka cases that day.The patients were in the room but not quite completely under.Not sure how you would consider that in terms of being ¿under anesthesia¿ as they only really do spinals at this hospital.The solution hasn¿t been resolved.They are waiting for official word, but as for now if they continue to come up with the grease or gray stuff they are deeming them unsterile and rejecting them.The procedure was completed successfully.I do not need replacements unless you deem it necessary." case type unknown.
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Manufacturer Narrative
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Reported event: it was reported that all case day the scrub nurse reported a grey greasy substance rubbing off onto gloves from the attachment pieces.We have three complete sets and all sets had to be re-run and flashed all day and still came up with the grey grease.The scrub nurse did not want to accept this onto the back table as no one could definitively state whether or not it was sterile.The or manager is wondering a couple things.One, is this happening at other accounts? if so, how are they navigating this? two, is there anything in writing that states that when this does occur, it is sterile and okay to proceed with the case? according to the manager, if there was something in writing the scrub nurse and techs wouldn¿t be able to refuse taking the attachments at their own discretion.Looking for some direction for the management and sterilization department.Product evaluation and results: not performed as no items were returned.The failure cannot be determined from the images provided in the communication log.Product history review: review of the device history records indicate (b)(4) were manufactured and (b)(4) accepted into final stock on 08/30/2018.Review of qt 18-08-0122 revealed that the non conformance is not related to the failure alleged.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 212186, lot 35080718 shows 1 additional complaints related to the failure in this investigation.The complaint is (b)(4).Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.H3 other text : device not returned.
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Search Alerts/Recalls
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