ENDO DISSECT

Additional Manufacturer Narrative

POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE EVENT REPORT ALLEGES THE PRODUCT WAS USED IN A SURGICAL PROCEDURE. THE ARTICULATION KNOB WAS SHEARED OFF AND DETACHED FROM THE HANDLE. THE DEVICE COULD NO LONGER BE ARTICULATED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. REPLICATION OF THE REPORTED EVENT CAN OCCUR WHEN APPLYING EXCESSIVE FORCE TO THE ARTICULATION KNOB BY ROTATING TOO FAR AND FORCING IT. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

Description of Event or Problem

ACCORDING TO THE REPORTER: DURING THE PROCEDURE, THE LEVER WHICH IS USED TO ARTICULATE THE DEVICE WAS BROKEN.

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THE DEVICE. THE ARTICULATION KNOB WAS SHEARED OFF AND DETACHED FROM THE HANDLE. THE DEVICE COULD NO LONGER BE ARTICULATED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. REPLICATION OF THE REPORTED EVENT CAN OCCUR WHEN APPLYING EXCESSIVE FORCE TO THE ARTICULATION KNOB BY ROTATING TOO FAR AND FORCING IT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER: AS PER THE ADDITIONAL INFORMATION RECEIVED, PATIENT STATUS IS STABLE. THERE WAS NO PATIENT INJURY.