GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE APPEARED TO BE NO ISSUES WITH THE RETURNED COUPLER RINGS, HOWEVER, IT IS UNKNOWN WHAT MAY HAVE TRANSPIRED DURING PREPARATION FOR THE SURGICAL PROCESS THAT MAY HAVE CAUSED THE RING TO BECOME DISLODGED. THERE IS POTENTIAL THAT ACCIDENTAL UNDUE PRESSURE PLACED ON THE RING DURING PREPARATION FOR USE MAY HAVE CAUSED THE RING TO DISLODGE FROM THE JAW ASSEMBLY. THE REPORTED CONDITION COULD NOT BE CONFIRMED OR REFUTED, AND THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE MICROVASCULAR ANASTOMOTIC COUPLER DEVICE RING ¿FALL ITSELF¿. THIS ISSUE OCCURRED PRE-OPERATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS - (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.