STRYKER ENDOSCOPY-SAN JOSE FG, CINCHLOCK SS ANCHOR WITH INSERTER; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number CAT02462 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/11/2019 |
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 the patient experienced deep gluteal syndrome.
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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 experiencing deep gluteal syndrome 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 the patient experienced deep gluteal syndrome.
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Search Alerts/Recalls
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