BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUMOPERITONEUM NEEDLE 13CM

    MDR report key: 797318 · Received December 15, 2006

    Report

    Report Number
    797318
    Event Type
    Injury
    Date Received
    December 15, 2006
    Date of Event
    December 6, 2006
    Report Date
    December 14, 2006
    Manufacturer
    KARL STORZ
    Product Code
    FHP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE OF A DIAGNOSTIC LAPAROSCOPY, LASER OF ENDOMETRIOSIS AND APPENDECTOMY, A VASCULAR INJURY OCCURRED. THE VERESS NEEDLE WAS INSPECTED AND APPEARED TO BE FUNCTIONING NORMALLY. THREE ATTEMPTS WERE MADE TO PLACE THE VERESS NEEDLE INTO THE PERITONEAL CAVITY. HOWEVER, AFTER EACH ATTEMPT, THE PT PRESSURE WAS HIGH INDICATING PLACEMENT WAS NOT IN THE PERITONEAL CAVITY. THE VERESS NEEDLE SHEATH DID NOT RETRACT COMPLETELY OVER THE BLUNT EDGE. DURING THE BOWEL MANIPULATION FOR THE APPENDECTOMY, A RETROPERITONEAL HEMATOMA WAS NOTED. A DEFECT IN THE PERITONEUM WAS NOTED AT THE LEVEL OF THE UMBILICUS BELOW WHERE THE VERESS NEEDLE HAD BEEN INSERTED. VASCULAR SURGERY WAS CONSULTED AND NO FURTHER INDICATION FOR FURTHER EXPLORATION. CT SCAN WAS DONE POSTOPERATIVELY AND SERIAL HEMATOCRITS WERE DONE TO MONITOR THE HEMATOMA. PT WAS ADMITTED TO THE HOSPITAL POSTOPERATIVELY FOR MONITORING. PT DISCHARGED ON 12/06 IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMOPERITONEUM NEEDLE 13CM VERESS NEEDLE FHP KARL STORZ * *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization