BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUCLEAR

    MDR report key: 7814327 · Received August 24, 2018

    Report

    Report Number
    1643264-2018-02056
    Event Type
    Injury
    Date Received
    August 24, 2018
    Date of Event
    August 23, 2016
    Report Date
    September 11, 2018
    Manufacturer
    MITG - OKLAHOMA CITY
    Product Code
    HIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN ASSESSED TO BE CONSIDERED A SERIOUS INJURY AN IS DOCUMENTED AS A COMPLAINT. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    DURING A STUDY TO COMPARE HYSTEROSCOPIC MORCELLATION USING THE TRUCLEAR 8.0 TISSUE REMOVAL SYSTEM VERSES LOOP RESECTION USING A BIPOLAR RESECTOSCOPE FOR THE REMOVAL OF PLACENTAL REMNANTS; IT WAS REPORTED THAT SERIOUS ADVERSE EVENTS INCLUDED PERFORATION AT DILATION WITH CONSEQUENCES IN 4 PATIENTS IN THE HYSTEROSCOPIC MORCELLATION GROUP (DISCONTINUATION: N = 2, INCOMPLETE REMOVAL: N = 1, EXCESSIVE POSTOPERATIVE PAIN DURING BREASTFEEDING WITH 1-NIGHT READMISSION: N = 1). 3 ADDITIONAL CASES OF PERFORATION OCCURRED IN THIS GROUP, HOWEVER THE PROCEDURE CONTINUED WITHOUT FURTHER EVENT. ALL OF THE PERFORATION EVENTS OCCURRED IN PATIENTS WITH PLACENTAL REMNANTS AFTER TERM DELIVERY OR CESAREAN SECTION. ARTICLE TITLE: HYSTEROSCOPIC MORCELLATION VERSUS LOOP RESECTION FOR REMOVAL OF PLACENTAL REMNANTS: A RANDOMIZED TRIAL PUBLISHED IN: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY, VOL 23, NO 7, NOVEMBER/DECEMBER 2016.

    Additional Manufacturer Narrative · 1

    TITLE HYSTEROSCOPIC MORCELLATION VERSUS LOOP RESECTION FOR REMOVAL OF PLACENTAL REMNANTS: A RANDOMIZED TRIAL JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY, VOL 23, NO 7,2016. DATE OF PUBLICATION: 23 AUG 2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN REASSESSED. THE EVENT IS NO LONGER CONSIDERED A SERIOUS INJURY, AND IS NOW CLASSIFIED AS A NOT A COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THOUGH NO DEVICE FAILURE WAS REPORTED IN THE ARTICLE, THIS EVENT HAS BEEN ASSESSED TO BE CONSIDERED A SERIOUS INJURY AND IS DOCUMENTED AS A COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN REASSESSED AND FOUND TO BE A NON-MDR REPORTABLE COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THERE WERE SERIOUS ADVERSE EVENTS REPORTED INCLUDING PERFORATION AT DILATION IN THE HYSTEROSCOPIC MORCELLATION GROUP. THERE WERE THREE ADDITIONAL CASES OF PERFORATION IN THIS GROUP, HOWEVER THE PROCEDURE CONTINUED WITHOUT FURTHER EVENT. ALL OF THE PERFORATION EVENTS OCCURRED IN PATIENTS WITH PLACENTAL REMNANTS AFTER TERM DELIVERY OR CESAREAN SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653765 TRUCLEAR HYSTEROSCOPE (AND ACCESSORIES) HIH MITG - OKLAHOMA CITY 7209208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other