COUPLER, ZOOM, HD, C-MOUNT

Additional Manufacturer Narrative

THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

ON 05/31/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT (2) AR-3210-0006 COUPLERS ARE EXPERIENCING AN ISSUE WITH ZOOMING, AND AUTO FOCUSING. THE IMAGE IS NOT CENTERED ON THE TOWER. THIS OCCURRED ON (B)(6) 2022 DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CASE HAD TO BE ABORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 06/07/2022: THE PATIENT WAS SEDATED WITH TRANSABDOMINAL PREPERITONEAL BLOCK (TAPP). THERE WAS NO SKIN INCISION MADE, AN THE PROCEDURE WAS ABORTED.

Additional Manufacturer Narrative

THE COMPLAINT IS CONFIRMED. (1) UNPACKAGED AR-3210-0006 ZOOM COUPLER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED AN INTERNAL LENS WAS DETACHED AND REMAINED LOOSE INSIDE THE COUPLER. THE DEVICE ALSO PRODUCED A RATTLING SOUND WHEN SHOOK. FUNCTIONAL TESTING WITH A CAMERA HEAD REVEALED THE IMAGE WAS NOT CENTERED ON THE DISPLAY, AND THERE WERE ISSUES WITH ZOOMING AND FOCUSING. WITHOUT ADDITIONAL INFORMATION, A CAUSE CANNOT BE DETERMINED. HOWEVER, A PROBABLE CAUSE COULD BE ATTRIBUTED TO IMPACT WITH A HARD SURFACE, SUCH AS DROPPING THE DEVICE ON THE FLOOR.