COUPLER

Description of Event or Problem

IT WAS REPORTED THAT A 1.5MM COUPLER WAS NOT CLOSING PROPERLY; THE RING WAS NOT ABLE TO FULLY ATTACH. THIS WAS DISCOVERED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

INITIAL REPORTER ADDRESS: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. VISUAL INSPECTION WAS PERFORMED COUPLER RINGS SHOWED THAT ONE OF THE 1.5MM COUPLER RINGS HAD BECOME SLIGHTLY DISPLACED FROM THE JAW ASSEMBLY. THE RAIL OF ONE SIDE OF THE COUPLER RING WAS NOT SEATED FULLY IN THE SLOT OF THE JAW ON THE LEFT SIDE OF THE JAW ASSEMBLY. WITH THE RING NOT FULLY SEATED IN THE SLOT OF THE JAW ASSEMBLY, APPROXIMATION OF THE COUPLER RINGS COULD NOT BE COMPLETED. THEREFORE, THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.