PENTAX

Description of Event or Problem

ON 15-JUL-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL HOT HEMOSTASIS FORCEPS MODEL H-S2518, SERIAL NUMBER (B)(6) IN JAPAN. WHEN A BIPOLAR HEMOSTATIC FORCEPS WAS CONNECTED TO THE HIGH-FREQUENCY ELECTROSURGICAL UNIT AND THE FOOTSWITCH WAS PRESSED, NO CURRENT WAS TRANSMITTED. THE HEMOSTASIS PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE, AND NO PATIENT HARM OCCURRED. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Additional Manufacturer Narrative

G4: THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. THE DEVICE IN QUESTION WAS CONFIRMED TO HAVE BEEN DISCARDED BY THE MEDICAL FACILITY. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

Additional Manufacturer Narrative

H4: DEVICE MANUFACTURE DATE IS UNKNOWN. CORRECTION INFORMATION: B4: DATE OF THIS REPORT - UPDATED, G6: FOLLOW-UP #: 1, H2: IF FOLLOW-UP, WHAT TYPE? - UPDATED, H3: DEVICE EVALUATED BY MANUFACTURER - "NO" TO "YES", H6: CODES UPDATED - TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. ADDITIONAL INFORMATION: D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI), H11: EVALUATION SUMMARY. EVALUATION SUMMARY: THE REPORTED EVENT OCCURRED WHEN A BIPOLAR HEMOSTATIC FORCEPS WAS CONNECTED TO THE HIGH-FREQUENCY ELECTROSURGICAL UNIT (ERBE/VIO3) AND THE FOOTSWITCH WAS PRESSED, BUT NO CURRENT WAS TRANSMITTED. THE PRODUCT IN QUESTION WAS DISCARDED AT THE FACILITY AND THEREFORE COULD NOT BE INVESTIGATED. BASED ON THE INVESTIGATION, THE FOLLOWING FACTORS COULD HAVE CAUSED THE CONDUCTION ISSUE, BUT THE EXACT CAUSE COULD NOT BE IDENTIFIED: THE CUP SECTION WAS NOT IN FULL CONTACT WITH THE HEMOSTASIS AREA, AND SINCE THE CURRENT WAS ABOUT TO EXCEED THE SET VALUE, THE CONTROL FUNCTION OF THE ELECTROSURGICAL UNIT (VIO3) MAY HAVE BEEN ACTIVATED. APPLYING POWER WHILE THE CUP PORTION WAS NOT FULLY IN CONTACT WITH THE HEMOSTASIS SITE REDUCED THE CONTACT AREA BETWEEN THE ELECTRODE AND THE TISSUE, THEREBY DECREASING THE OUTPUT REQUIRED FOR HEMOSTASIS. BASED ON THE TREND ANALYSIS, THERE IS NO SIGNIFICANT INCREASE OR UPWARD TREND IN COMPLAINTS RELATED TO THIS FAILURE MODE OR HAZARD. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THAT THE BIPOLAR HEMOSTATIC FORCEPS WAS MANUFACTURED BY THE MANUFACTURER ON 16-OCT-2024 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE CONSIDERS THIS MEDWATCH REPORT CLOSED.