UNK_PENCILS - REUSABLE

Additional Manufacturer Narrative

(B)(4) DATE SENT 9/4/2025 D4 BATCH # UNK B3: ONLY EVENT YEAR KNOWN: 2025. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. NO LOT OR BATCH NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY COULD NOT BE DONE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

PER USER FACILITY MEDWATCH FORM, #MW5175298, DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED THAT PRIOR TO USE, FLAME AND SMOKE WERE OBSERVED ON THE CORD CONNECTED TO THE MONOPOLAR 1 UNIVERSAL RECEPTACLE. THE CORD WAS BURNED AND BROKEN. THE CORD USED WAS A NON-MANUFACTURED. THERE WAS NO PATIENT INVOLVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE AVAILABILITY WAS UNKNOWN.