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Additional Manufacturer Narrative

LEGAL MANUFACTURER: HCS HINO - 7-127 ASAHIGAOKA 4-CHOME JAPAN HINO-SHI TOKYO, 191-8503. A1, 2, 3, 4, 5, 6 - PATIENT INFORMATION NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

Description of Event or Problem

IT WAS REPORTED THAT DOUBLE IMAGING OCCURRED AND A CLINICAL DECISION WAS MADE TO TAKE THE PATIENT TO SURGERY. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT AND PATIENT DETAILS HAS BEEN REQUESTED.

Description of Event or Problem

ADDITIONAL INFORMATION: THE PATIENT PRESENTED WITH SYMPTOMS SUGGESTIVE OF AN ECTOPIC PREGNANCY AND WAS NOTED TO BE NINE WEEKS PREGNANT, WITH NO PRIOR SCANS PERFORMED. A TRANSABDOMINAL ULTRASOUND REVEALED AN INTRAUTERINE PREGNANCY, WITH THE FETUS MEASURING 22.4 MM. ADDITIONALLY, A SECOND GESTATIONAL SAC WAS OBSERVED IN THE LEFT ABDOMINAL AREA, CONTAINING A FETUS MEASURING 20.9 MM, RAISING CONCERN FOR A HETEROTOPIC PREGNANCY. HOWEVER, UPON PERFORMING A LAPAROSCOPY, NO ECTOPIC PREGNANCY WAS IDENTIFIED, AND ONLY A SINGLE INTRAUTERINE PREGNANCY WAS CONFIRMED.

Additional Manufacturer Narrative

B4, 5; G1, 3, 6; H2, 3, 6. H3: GE HEALTHCARE HAS COMPLETED ITS INVESTIGATION. FOLLOWING THE RETURN OF THE CONSOLE AND PROBE, A VISUAL INSPECTION REVEALED NO PHYSICAL ABNORMALITIES IN EITHER THE PROBE OR THE CONSOLE, INCLUDING THEIR CONNECTORS. ENGINEERING WAS NOT ABLE TO REPRODUCE THE ISSUE DURING PRELIMINARY TESTING. THE PROBE AND CONSOLE WERE FUNCTIONING AS INTENDED, WITH NO DESIGN OR MANUFACTURING DEFECTS IDENTIFIED. ENGINEERING PERFORMED SIMULATION TESTING OF THE CONNECTIVITY BETWEEN THE PROBE AND CONSOLE. THE SIMULATION TESTING WAS DESIGNED TO EMULATE THE FUNCTIONAL IMPACT OF VISIBLE DEBRIS CONTAMINATION CAUSING OBSTRUCTION OF THE MECHANICAL OR ELECTRICAL INTERFACE. THIS TESTING RESULTED IN A DOUBLE IMAGE, INDICATING THAT A CONNECTIVITY ISSUE WAS THE MOST LIKELY ROOT CAUSE. WHILE THE EXACT SOURCE OF CONTAMINATION COULD NOT BE CONFIRMED, IT IS SUSPECTED THAT ENVIRONMENTAL OR HANDLING FACTORS MAY HAVE INTRODUCED VISIBLE DEBRIS DURING USE, LEADING TO INTERMITTENT CONNECTIVITY ISSUES. THE SERVICE MANUAL INCLUDES CLEANING INSTRUCTIONS FOR PROBE CONNECTORS IN CHAPTER 10: CARE & MAINTENANCE, WHICH STATES: PROBE CONNECTORS REMOVE DUST AND DIRT FROM ALL PROBE CONNECTORS. USE A VACUUM CLEANER IF DUST IS VISIBLE. NO ISSUES WERE FOUND IN THE MANUFACTURING OR HANDLING PROCESSES. NO FURTHER ACTION IS PLANNED BY GE HEALTHCARE.