BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2031306 · Received March 22, 2011

    Report

    Report Number
    9680933-2009-00007
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    October 30, 2008
    Report Date
    March 18, 2011
    Manufacturer
    DELTEX MEDICAL LIMITED
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DELTEX MEDICAL LTD DOES NOT ACCEPT THAT ITS DOPPLER PROBE WAS THE CAUSE OF THE INCIDENT. NONE-THE-LESS, WE HAVE PRO-ACTIVELY REVIEWED THE INSTRUCTIONS FOR USE OF ALL DOPPLER PROBES AND MONITOR. IN REVIEWING INSTRUCTIONS FOR USE FOR BOTH MONITOR AND PROBES, WE CONCLUDE THAT A CAUTION IN PASSING DEVICES OTHER THAN THE OESOPHAGEAL PROBE FOR BARIATRIC PTS IS UNNECESSARY AND THAT THE RESPONSIBILITY FOR THE DECISION OF INSERT OTHER DEVICES INTO THE OESOPHAGUS MUST REST WITH THE USER AND THAT THE HOSPITAL SHOULD REVIEW THEIR PRACTICES. DELTEX MEDICAL DOES NOT ACCEPT CAUSALITY FOR THIS ADVERSE INCIDENT.

    Description of Event or Problem · 1

    REPORTED COMPLAINT: ON THE (B)(6) 2009, AN EMAIL WAS RECEIVED FROM (B)(6) RELATED TO A PERFORATION OF THE OESOPHAGUS REPORTED BY DR (B)(6) (INTENSIVE CARE AND ANAESTHESIA CONSULTANT) AT THE (B)(6) HOSPITAL. DR (B)(6) WAS CONTACTED ON THE (B)(4) BY OUR CLINICAL APPLICATION SPECIALIST (B)(4) AND IT WAS FOUND THAT THE INCIDENT HAD OCCURRED ON THE (B)(6) 2008. CIRCUMSTANCES OF THE INCIDENT: FROM THE INFO RECEIVED FROM DR (B)(6), THE FOLLOWING PERSONNEL WERE INVOLVED IN THE INCIDENT: DR (B)(6), DR (B)(6) (ANAESTHETICS), (B)(6) (SURGERY), AND DR (B)(6) (RADIOLOGY). OUR UNDERSTANDINGS OF EVENTS ARE AS FOLLOWS: DURING GASTRIC BYPASS SURGERY ON A (B)(6) MORBIDLY OBESE FEMALE (APPROX (B)(6)). THE DOPPLER PROBE WAS PLACED FOR CARDIAC OUTPUT MONITORING. IN ADDITION, A 32F GAUGE GASTRIC BOUGIE WAS PASSED INTO THE STOMACH FOR POUCH SIZING TOGETHER WITH A 16G GAUGE NG TUBE. THE DOPPLER PROBE WAS ALREADY IN PLACE WHEN THE OTHER DEVICES WERE PASSED BY DR (B)(6) AND APPARENTLY NO UNEXPECTED RESISTANCE OR FORCE WAS USED. ANAESTHESIA AND SURGERY WERE UNEVENTFUL WITH NO PROBLEMS NOTED AT THE TIME, HOWEVER, POST-OPERATIVELY, THE PT COMPLAINED OF SOME PAIN ON SWALLOWING ON THE EVENING AFTER SURGERY BUT CONTINUED ORAL FLUIDS AND MEDICATION. THE NEXT DAY, A CONTRAST SWALLOW WAS PERFORMED (ROUTINELY CONDUCTED ON ALL GASTRIC BYPASSES BUT REQUESTED EARLY BECAUSE OF DYSPHAGIA) AND A LEAK WAS DETECTED INTO MEDIASTINUM CONSISTENT WITH A TRANSMURAL LEAK IN THE UPPER THIRD OF THE OESOPHAGUS. SUBSEQUENTLY, A NASOGASTRIC TUBE WAS PASSED UNDER X-RAY SCREENING BEYOND THE OESOPHAGUS INTO THE GUT TO GIVE ACCESS FOR TUBE FEEDING. THE PT WAS THEN GIVEN NIL BY MOUTH AND PERFORATION SEALED/HEALED SPONTANEOUSLY. GASTRIC BYPASS PROCEDURE: THE SURGICAL PROCEDURE REQUIRES THE FORMATION OF A POUCH IN THE STOMACH GUIDED BY A 32F GAUGE BOUGIE, WHICH IS PASSED FROM THE MOUTH DOWN THE OESOPHAGUS BY THE ANAESTHETIST. LATER, AFTER THE REMOVAL OF THE BOUGIE, A GASTRIC TUBE (SIZE 16) IS PASSED ORALLY INTO THE POUCH VIA THE OESOPHAGUS TO TEST FOR LEAKS BY INJECTION OF METHYLENE BLUE DYE. THE CARDIOQ SYSTEM (MONITOR AND ASSOCIATED PROBE) IS EXTENSIVELY USED FOR INTRA-OPERATIVE MONITORING AS FLOW-GUIDED THERAPY YIELDS BETTER OUTCOMES IN MAJOR SURGERY. THE CARDIOQ IS COMMONLY USED IN BARIATRIC CASES AND THE PROBE REMOVED AT THE END OF THE CASE. PT CONDITION: THE PT MADE A GOOD RECOVERY FOLLOWING SUBSEQUENT CONTRAST CT ON (B)(6) 2008, DEMONSTRATING NO FURTHER LEAK AND DISCHARGED ON (B)(6) 2008, HAVING RESUMED EATING. HOSPITAL FINDINGS: DR (B)(6) FINAL INCIDENT REPORT FORM (INCIDENT NO. (B)(4)) CONCLUDED: SURGICAL MANIPULATION OF THE LOWER OESOPHAGUS CAN ITSELF LEAD TO PERFORATION, HOWEVER, IT APPEARS THE LEAK WAS AT A MUCH HIGHER LEVEL. AS THE OESOPHAGEAL DOPPLER PROBE, BOUGIE AND NASOGASTRIC TUBE WERE ALL PASSED DOWN THE OESOPHAGUS, IT IS NOT POSSIBLE TO ASCERTAIN WHICH WAS RESPONSIBLE FOR THE PERFORATION. HAVING BOTH DOPPLER PROBE AND BOUGIE IN THE OESOPHAGUS AT THE SAME TIME MAY BE AN ADDITIONAL RISK FOR INJURY TO THE WALL OF THE OESOPHAGUS. THE BOUGIE WAS THE LARGEST OF THE ITEMS USED WHILST THE DOPPLER PROBE IS RELATIVELY FLEXIBLE. THE NG TUBE IS USUALLY TOO SOFT TO PUSH WITH ANY FORCE. HOSPITAL CONCLUSION: OESOPHAGEAL PERFORATION IS A RECOGNIZED BUT RARE COMPLICATION OF INSTRUMENTATION IN THE OESOPHAGUS. IT IS NOT POSSIBLE TO SPECIFY WHICH OF THE 3 DIFFERENT ITEMS PASSED INTO THE OESOPHAGUS CAUSED THE PERFORATION BUT GIVEN THE LOCATION OF THE LEAK, INSTRUMENTATION MUST HAVE BEEN THE CAUSE. FORTUNATELY, THE PROBLEM WAS DETECTED PROMPTLY AND THE PT MADE A GOOD RECOVERY WITH NO LONG-TERM DAMAGE TO THE OESOPHAGUS OR ITS FUNCTION, ALBEIT WITH A LONGER THAN AVERAGE POST-OP STAY AND THE RADIATION EXPOSURE OF A CT SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE ITX DELTEX MEDICAL LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR