STRYKER ENDOSCOPY-SAN JOSE ICONIX 2 TT WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2.0MM XBRAID TT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 3910500322 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problem
Pain (1994)
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Event Date 06/29/2021 |
Event Type
malfunction
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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 had post-op pain resulting in the anchors being removed.
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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 complaining of buttock pain and also difficulty sitting.Probable root cause: design; sutures abrasive; application; excessive force used to tension repair.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
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Event Description
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It was reported that the patient had post-op pain resulting in the anchors being removed.
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Search Alerts/Recalls
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