CAPIO

Additional Manufacturer Narrative

APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF DART DETACHMENT. UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS CAPIO SLIM DEVICE UNDERWENT A THOROUGH ANALYSIS. VISUAL INSPECTION OF THE DEVICE DID NOT REVEAL ANY ANOMALIES. UPON FUNCTIONAL INSPECTION, THE CARRIER WAS ABLE TO MOVE IN AND OUT. AFTER DEPLOYING THE CARRIER, THE CAGE WAS ABLE TO CATCH THE SUTURE. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE REPORTED EVENT OF "DART DETACHMENT" WAS NOT CONFIRMED. A CONCLUSION CODE OF NO PROBLEM DETECTED WAS ASSIGNED TO THIS INVESTIGATION. THIS CONCLUSION WAS SELECTED BECAUSE IT WAS REPORTED THAT THE DART DETACHED FROM THE SUTURE, HOWEVER, AFTER VISUAL AND FUNCTIONAL INSPECTIONS IN THE COMPLAINT DEVICE IT WAS NOT POSSIBLE TO IDENTIFY ANY EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT ON THE DEVICE. ALSO, THE EVIDENCE FROM THE PRODUCT RECORD REVIEW DID NOT IDENTIFY A POTENTIAL PRODUCT QUALITY ISSUE.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO DEVICE, THE DART DETACHED FROM THE SUTURE. ANOTHER CAPIO SLIM DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATION WAS REPORTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO DEVICE, THE DART DETACHED FROM THE SUTURE. ANOTHER CAPIO SLIM DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATION WAS REPORTED.

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF DART DETACHMENT.