STRYKER ENDOSCOPY-SAN JOSE FG, CINCHLOCK SS ANCHOR WITH INSERTER; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number CAT02462 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Fluid Discharge (2686); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2021 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that there was post-op patient pain and fluid around the surgical site.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: patient pain and fluid around the surgical site.Probable root cause: design.- wrong raw material or manufacturing agent selected.- in-process cleaning not effective at removing manufacturing residuals.- not enough strict controls placed on raw material source and purity process.- contamination during process.- in-process cleaning not performed to spec application.-contamination of devices.The reported failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that there was post-op patient pain and fluid around the surgical site.
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Search Alerts/Recalls
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