BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DP6 PROBE

    MDR report key: 3003845 · Received March 12, 2013

    Report

    Report Number
    9680933-2013-00001
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 1, 2013
    Manufacturer
    DELTEX MEDICAL LIMITED
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUCTIONS FOR USE: THE DELTEX MEDICAL DP6 PROBE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING INFO WHICH MAY BE RELEVANT TO THIS EVENT: WARNINGS - DO NOT USE IN THE FOLLOWING SITUATIONS, PT HARM MAY RESULT: USE ONLY BY TRAINED AND QUALIFIED PERSONNEL, OR UNDER SUCH SUPERVISION. CONTRAINDICATIONS: DO NOT USE WITH CARCINOMA OF THE PHARYNX; LARYNX; OESOPHAGUS. NOT FOR USE IN PTS WITH PHARYNGO-ESOPHAGO-GASTRIC PATHOLOGY AND/OR SEVERE BLEEDING DIATHESES. FURTHER THE PROBE TIP OF THE DELTEX MEDICAL DP6 OESOPHAGEAL DOPPLER PROBE IS SOFT AND FLEXIBLE BEING MANUFACTURED FROM MEDICAL GRADE SILICONE RUBBER. FURTHER THERE IS A REGION BEHIND THE TIP DESIGNED TO ALLOW FLEXIBILITY. NOTIFICATION AND SUBSEQUENT EVENTS: THE (B)(6) ON BEHALF OF THE DEPT OF HEALTH, SOCIAL SVS AND PUBLIC SAFETY (DHSSPSNI), IS THE FOCAL POINT FOR REPORTING ADVERSE INCIDENTS INVOLVING MEDICAL DEVICES, NON-MEDIAL EQUIPMENT, PLANT AND BUILDINGS IN (B)(6). THE (B)(6) WORK CLOSELY WITH THE (B)(4) CONCERNING MEDICAL DEVICE SAFETY ON A UK WIDE BASIS. ON (B)(4) 2012, ATTEMPTS WERE MADE TO CONTACT THE REPORTER BY TELEPHONE USING THE CONTACT DETAILS PROVIDED IN THE (B)(6) ADVERSE INCIDENT REPORT (B)(4) WITHOUT SUCCESS. SUBSEQUENTLY A LIST OF QUESTIONS WERE SENT TO THE REPORTED VIA EMAIL TO FURTHER UNDERSTAND THE CIRCUMSTANCES OF THE INCIDENT SO THAT AN INITIAL INCIDENT REPORT COULD BE FILED IN A TIMELY MANNER. ON THE (B)(6) WE RECEIVED A REPLY FROM THE REPORTER WITH THE RESPONSES TO THE QUESTIONS SENT. SUMMARY: FROM THE REPORTER'S RESPONSES TO THE QUESTIONS THE FOLLOWING CAN BE CONCLUDED: THE INCIDENT WAS LIFE THREATENING; HOWEVER, THE PT HAD NOT DIED. NO SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE THE PERFORATION. AT THIS TIME DELTEX MEDICAL IS UNCERTAIN TO THE EXACT POSITION OF THE PERFORATION SAVE THAT THEY WERE IN THE MID TO LOWER THIRD OF THE OESOPHAGUS. ESTABLISHING THE EXACT POSITION COULD BE IMPORTANT IN ASCERTAINING WHETHER THEY WERE WITHIN THE RANGE OF THE PROBE TIP POSITION. DELTEX MEDICAL COMMENTS: FURTHER TO RESPONSES FROM THE REPORTER THE FOLLOWING IS STILL UNCLEAR: WHETHER OTHER DEVICES/DRUGS WERE BEING USED AT THE SAME TIME.

    Description of Event or Problem · 1

    REPORTED COMPLAINT: DELTEX MEDICAL WAS MADE AWARE OF THIS ADVERSE EVENT BY (B)(6). THE INCIDENT CONCERNING A SUSPECTED PERFORATED ESOPHAGUS WAS REPORTED TO THE (B)(4). THE INCIDENT OCCURRED ON (B)(6) 2003. CIRCUMSTANCES OF THE INCIDENT: A (B)(6) FEMALE WAS ADMITTED TO THE (B)(6) HOSPITAL FOR ABDOMINOPERINEAL RESECTION. THE PT WEIGHED (B)(6). THE CASE PROCEEDED UNEVENTFULLY; HOWEVER, 24 HOURS AFTER SURGERY THE PT BECAME UNWELL AND WAS FOUND TO HAVE A PERFORATED OESOPHAGUS. PT CONDITION POSTOPERATIVELY: THE PT REMAINS ON ICU NON-VENTILATED AND THE OUTCOME IS UNCLEAR AT THIS MOMENT IN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102927 DP6 PROBE EXTRAVASCULAR BLOOD FLOW PROBE IYN DELTEX MEDICAL LIMITED DP6 7801X

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L