PENTAX

Additional Manufacturer Narrative

D4 UDI: "NOT DISTRIBUTED IN USA", BECAUSE PRODUCTS ARE NO DISTRIBUTED IN USA PRODUCTS, BUT SIMILAR DEVICE PRODUCT IS LISTED IN USA. G4: THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. FILE ATTACHMENTS.

Description of Event or Problem

COVER OF THE NEW SAS-M10 MONITOR SMOKED DURING SWITCH ON THE FIRST TIME 08-AUG-2024_WE ASKED FOR FURTHER INFORMATION AND PICTURES NO FURTHER INFORMATION. TEH MONITOR WAS SWITCHED OFF AND SEND BACK TO PENTAX MEDICAL EMEA FOR REPLACEMENT. THIS EVENT OCCURRED AT THE TIME OF INSTALLATION. THERE WAS NO REPORT OF PATIENT HARM. 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

CORRECTION INFORMATION B4: DATE OF THIS REPORT D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) # G6: FOLLOW UP #1 H2: IF FOLLOW-UP, WHAT TYPE? H3: DEVICE EVALUATED BY MANUFACTURE H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT. ADDITIONAL INFORMATION H4: DEVICE MANUFACTURE DATE. EVALUATION SUMMARY BASED ON THE INVESTIGATION, A POTENTIAL ROOT CAUSE OF THIS FAILURE IS THE SYSTEM CONTROL PCB FAILURE OR THE SHORT OF POWER SUPPLY UNIT. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. THE DEVICE HAS BEEN REPLACED. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 26-AUG-2022 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS AND WAS RELEASED ACCORDINGLY. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.