Description of Event or Problem · 0
DEAR MEDWATCH TEAM: (B)(6) IS SUBMITTING THIS NOTIFICATION TO INFORM FDA THAT WE HAVE RECEIVED INFORMATION REGARDING A MALFUNCTION OF A THIRD-PARTY REMANUFACTURED VERSION OF A DEVICE ORIGINALLY MANUFACTURED BY OUR COMPANY. BASED ON THE INFORMATION AVAILABLE, THE EVENT MAY MEET THE CRITERIA FOR REPORTABILITY UNDER 21 CFR PART 803. HOWEVER, (B)(6) DID NOT MANUFACTURE, REMANUFACTURE, OR DISTRIBUTE THE DEVICE INVOLVED IN THIS EVENT. ACCORDINGLY, (B)(6) IS NOT RESPONSIBLE FOR MAKING A FINAL REPORTABILITY DETERMINATION AND, IF NEEDED, SUBMITTING A MEDICAL DEVICE REPORT (MDR) TO FDA. BASED ON OUR REVIEW OF THE MAUDE DATABASE, IT DOES NOT APPEAR THAT THE REMANUFACTURED, RESTORE ROBOTICS, HAS REPORTED THIS EVENT. WE ARE THEREFORE PROVIDING THIS INFORMATION TO FDA OUT OF AN ABUNDANCE OF CAUTION TO ENSURE APPROPRIATE VISIBILITY INTO A POTENTIAL SAFETY CONCERN, AND TO FULFILL OUR REGULATORY RESPONSIBILITIES PURSUANT TO 21 C.F.R. § 803.22(B)(2). ON OR ABOUT MARCH 26, 2026, (B)(6) RECEIVED THROUGH ITS RETURN MERCHANDISE AUTHORIZATION (RMA) PROCESS, MONOPOLAR CURVED SCISSORS (MCS) REMANUFACTURED BY RESTORE ROBOTICS, AN AFFILIATE OF ICONOCARE. THE DEVICE ENTERED OUR SYSTEM BEFORE WE WERE AWARE IT WAS NOT AN (B)(6) INSTRUMENT. THE DEVICE WAS RECEIVED FROM (B)(6) HOSPITAL (B)(6) WITH A COMPLAINT INDICATING ¿DULL TIPS.¿ THE DEVICE DISPLAYED CLEAR THERMAL DAMAGE CONSISTENT WITH AN ARCING EVENT AT THE EXTENSION TUBE. SPECIFICALLY, THERE WAS CLEAR EVIDENCE OF THERMAL DAMAGE (CHARRING/MELTING) AT THE EXTENSION TUBE ¿ PROXIMAL CLEVIS INTERFACE, AND APPARENT DAMAGE AND DEFORMATION TO EXTENSION TUBE SEALING FEATURES, CREATING A LIKELY FLUID LEAKAGE PATH EVEN WITH THE TIP-COVER PROPERLY INSTALLED. (B)(6) CONDUCTED ROBUST ELECTRICAL SAFETY TESTING ON THIS INSTRUMENT, SPECIFICALLY, MAINS DIELECTRIC (HIPOT) TESTING. NOT ONLY DID THIS PARTICULAR INSTRUMENT FAIL THE TESTING, BUT IT ALSO HAD VISIBLE CHAR RESIDUE (ARC-TRACKING), OBSERVABLE ALONG THE SURFACE OF THE MCS EXTENSION TUBE SECTION OF THE MAIN TUBE, INDICATING A DIRECT SHORT ELECTRICAL PATHWAY VIA THE DAMAGED SEALING SURFACES OF THE MCS EXTENSION TUBE. WE OBSERVED THE LASER MARKING ON THE DEVICE THAT STATED, ¿REMANUFACTURED BY RESTORE ROBOTICS. NOT AFFILIATED WITH ORIGINAL MFR. (B)(4),¿ WITH SERIAL NUMBER (B)(6). THE RFID CHIP ON THIS PARTICULAR INSTRUMENT INDICATED THAT THREE CLINICAL USES REMAINED ON THE ADDITIONAL LIVES ADDED TO THE DEVICE BY THE REMANUFACTURER. WE ARE NOT AWARE OF A SPECIFIC ADVERSE EVENT THAT OCCURRED AS A RESULT OF THIS PARTICULAR EVENT; HOWEVER, THERE ARE POTENTIAL RISKS ASSOCIATED WITH DEVICES DEMONSTRATING THESE FAILURES, NOTABLY, PATIENT BURNS, UNINTENDED TISSUE INJURY, BOWEL PERFORATION, OR DEATH. FURTHER, HAD THIS EVENT OCCURRED WITH (B)(6) DEVICE, (B)(6) MDR REPORTING PROCEDURE WOULD NECESSITATE FILING AN MDR, AS SUCH A MALFUNCTION WOULD BE LIKELY TO CAUSE SERIOUS INJURY IF IT WERE TO RECUR. (B)(6) DID NOT PLACE THIS DEVICE INTO COMMERCIAL DISTRIBUTION AND IS THEREFORE NOT THE ENTITY RESPONSIBLE FOR ASSESSING THE REPORTABILITY OF THIS COMPLAINT AND MAKING THE REPORT TO FDA, SHOULD ONE BE NEEDED. AS NOTED, BASED ON OUR REVIEW OF THE MAUDE DATABASE, IT DOES NOT APPEAR THAT ICONOCARE OR RESTORE ROBOTICS HAS SUBMITTED AN MDR REGARDING THIS EVENT, AND WE ARE THEREFORE PROVIDING THIS INFORMATION TO FDA SO THAT IT MAY FOLLOW-UP WITH THE REMANUFACTURER AS APPROPRIATE. WE ARE ALSO NOTIFYING RESTORE AND SENDING THIS PARTICULAR INSTRUMENT TO THEM. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).