BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVAGINAL 3.0 MM INTRODUCER

    MDR report key: 8902334 · Received August 16, 2019

    Report

    Report Number
    3003990090-2019-01485
    Event Type
    Injury
    Date Received
    August 16, 2019
    Report Date
    October 29, 2019
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    PWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TWO CAL-TV30 INSTRUMENTS HAVE BEEN RECEIVED AT COROPORATE (LOT # 46594) FOR INVESTIGATION. PER ENGINEERING ANALYSIS BOTH INSTRUMENTS OF CAL-TV30 PASSED TIP INSPECTIONT TEST AND ARE CONSIDERED TO BE WITHIN SPECIFICATION ACCORDING TO DRAWING 02-231 FOR TIP DIMENSIONING. CONCLUDING THIS ENGINEERING ANALYSIS, THE RETURNED INSTRUMENTS DEMONSTRATE MECHANICAL DEFORMITY DUE TO APPARENT MODIFICATION WHEN MEASURED TO THE DEVICE DRAWING AND SPECIFICATIONS. IT APPEARS THAT THE INSTRUMENTS WERE EQUALLY MODIFIED, WHICH AFFECTED THE FUNCTIONALITY OF THE INSTRUMENTS. MODIFICATION OF INSTRUMENTS IS CONTRAINDICATED IN THE WARNINGS SECTION OF THE INDICATIONS FOR USE (IFU), #10-193. THE DISPOSITION OF THESE INSTRUMENTS IS QUARANTINED AND NOT AVAILABLE FOR FUTURE USE.

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL DETAILS OF THE REPORTED EVENT AND NO FURTHER INFORMATION HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT. AWAITING INSTRUMENT RETURN FOR INVESTIGATION. A NEW SET OF INSTRUMENTS WERE SENT AS REPLACEMENTS TO THE FACILITY. LOT HISTORY RECORDS FOR INSTRUMENT ON FILE AT THE CUSTOMER INDICATES NO NON-CONFORMANCES OR DEVIATIONS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT BASED UPON THE REPORTED EVENT. THE RISK OF BLADDER/ORGAN PERFORATION IS A KNOWN POTENTIAL ADVERSE EVENT AND IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE DESARA TV PRODUCT IFU # 10-139-06.

    Description of Event or Problem · 1

    ON (B)(6) 2019, DR. (B)(6) REPORTS IN AN EMAIL: "I WAS HANDED A TROCAR THAT HAD LESS OF A CURVE AND I PUNCTURED THE BLADDER." SURGEON AND SALES REP WERE CONTACTED FOR FURTHER INFORMATION. ON 08/13/2019, SALES REP PROVIDES ADDITIONAL INFORMATION: "I MET WITH HER AND SHE SAID THE WRONG TROCAR WAS BROUGHT INTO THE OR. I AM GOING TOMORROW TO MEET WITH HER OR NURSE TO LOOK OVER ALL TROCARS THEY HAVE AND FIGURE OUT WHICH ONE WAS BROUGHT IN. SHE SAID SHE BELIEVED THE INSTRUMENT HANDLE ENDED IN A "30". SURGEON KEPT TRYING TO FIND THE CASE, PATIENT AND ALL THAT INFO AND COULDN'T FIND IT AND SAID SHE'D HAVE TO LOOK INTO IT FURTHER FOR ME. SHE SAID SHE REMEMBERED THE TROCAR INSTRUMENT ENDING IN 30 NOT 32 THOUGH. SHE UNFORTUNATELY DIDN'T HAVE MUCH PREPARED FOR ME OR MUCH INFORMATION. SHE SAID IT WAS EARLY THIS YEAR AND SHE HAD FINALLY JUST GOT AROUND TO CONTACTING US ABOUT IT. ALL SHE COULD TELL ME: SHE WAS DOING TRANSVAGINAL AND THE TROCARS LOOKED ALMOST IDENTICAL, BUT SHE NOTICED THE HANDLE SEEMED DIFFERENT. SHE THOUGHT MAYBE THEY GAVE HER THE SUPRAPUBIC INSTRUMENT VS TRANSVAGINAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694983 TRANSVAGINAL 3.0 MM INTRODUCER TRANSVAGINAL INTRODUCER PWJ CALDERA MEDICAL INC. 46594

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization