BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE DISTAL ATTACHMENT

    MDR report key: 14346170 · Received May 10, 2022

    Report

    Report Number
    8010047-2022-07954
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    March 18, 2021
    Report Date
    June 13, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K984358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT THE USER'S EXPERIENCES AND INVESTIGATION FINDINGS. THE DEVICES REFERENCED IN THIS REPORT WERE NOT RETURNED TO OLYMPUS FOR PHYSICAL EVALUATION. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICES COULD NOT BE REVIEWED SINCE THE SERIAL NUMBERS WERE NOT PROVIDED. OLYMPUS DOES NOT SHIP ANY DEVICE THAT DOES NOT MEET ALL DESIGN AND SAFETY SPECIFICATIONS. CONCLUSION: NO MALFUNCTION OF ANY OLYMPUS DEVICE WAS REPORTED IN ANY PROCEDURE DESCRIBED IN THIS ARTICLE. FROM THE INFORMATION REPORTED, IT IS PRESUMED THAT THE CAUSES OF THE REPORTED EVENTS ARE NOT DUE TO PRODUCT DEFECTS, BUT THE DEFINITIVE CAUSE COULD NOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION PROVIDED BY THE AUTHOR AND INVESTIGATION FINDINGS. THE DEVICES REFERENCED IN THIS REPORT WERE NOT RETURNED TO OLYMPUS FOR PHYSICAL EVALUATION. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICES COULD NOT BE REVIEWED SINCE THE SERIAL NUMBERS COULD NOT BE PROVIDED. OLYMPUS DOES NOT SHIP ANY DEVICE THAT DOES NOT MEET ALL DESIGN AND SAFETY SPECIFICATIONS. CONCLUSION: NO MALFUNCTION OF ANY OLYMPUS DEVICE WAS REPORTED IN ANY PROCEDURE DESCRIBED IN THIS ARTICLE. FROM THE INFORMATION REPORTED, IT IS PRESUMED THAT THE CAUSES OF THE REPORTED EVENTS ARE NOT DUE TO PRODUCT DEFECTS, BUT THE DEFINITIVE CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IN THE LITERATURE TITLED ¿REAL-WORLD EXPERIENCE OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR ULCERATIVE COLITIS-ASSOCIATED NEOPLASIA,¿ PATIENTS EXPERIENCED ADVERSE EVENTS AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-Q260JI USED IN THE PROCEDURES, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-Q260J USED IN THE PROCEDURES, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-650Q USED IN THE PROCEDURES, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS D-201-11804 USED IN THE PROCEDURES, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS FD-410LR USED IN THE PROCEDURES. STUDY BACKGROUND/AIM: PATIENTS WITH ULCERATIVE COLITIS (UC) HAVE AN INCREASED RISK OF COLORECTAL CANCER. SOME STUDIES HAVE RECENTLY INVESTIGATED ENDOSCOPIC RESECTION OF UC-ASSOCIATED NEOPLASIA (UCAN), BUT THE INDICATIONS FOR ENDOSCOPIC RESECTION OF UCAN REMAIN CONTROVERSIAL. THIS STUDY SOUGHT TO CLARIFY THE PROBLEMS ENCOUNTERED IN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR UCAN. METHODS: SEVENTEEN LESIONS IN 12 PATIENTS WITH UCAN (UCAN GROUP) AND 913 EPITHELIAL LESIONS IN 824 CONTROL PATIENTS WITHOUT UC (NON-UC GROUP) WERE EVALUATED. BOTH GROUPS UNDERWENT ESD BETWEEN JANUARY 2010 AND DECEMBER 2017 AT (B)(6). TREATMENT OUTCOMES OF THE 2 GROUPS WERE COMPARED RETROSPECTIVELY RESULTS: UNIVARIATE ANALYSIS SHOWED THAT THE MEAN TUMOR SIZE WAS SIGNIFICANTLY SMALLER IN THE UCAN GROUP THAN IN THE NON-UC GROUP (25.1 ± 26.7 MM VS. 31.9 ± 19.0; P = 0.0023); HOWEVER, THE R0 RESECTION RATE WAS SIGNIFICANTLY LOWER IN THE UCAN GROUP (70.6 VS. 92.9%; P = 0.001). MULTIVARIATE ANALYSIS SHOWED A SIGNIFICANTLY LOWER NEGATIVE HORIZONTAL MARGIN RATE IN THE UCAN GROUP (ODDS RATIO 11.3, 95% CONFIDENCE INTERVAL 3.588¿34.525; P = 0.000). CONCLUSION: ESD FOR UCAN IS ASSOCIATED WITH A LOW-NEGATIVE HORIZONTAL MARGIN RATE. WHEN PERFORMING ESD FOR UCAN, IT IS IMPORTANT TO EVALUATE THE ACCURACY OF THE UCAN DEMARCATION LINE, ESPECIALLY FOR FLAT LESIONS, USING WHITE-LIGHT IMAGING AND CHROMOENDOSCOPY AS WELL AS OTHER MODALITIES, INCLUDING BIOPSY OF SURROUNDING TISSUES. TWO OF THE 17 LESIONS (11.8%) WERE STENOSED AFTER ESD; ALL LESIONS WERE TREATED WITH CIRCUMFERENTIAL ESD (TABLE 3). ONE OF THE CASES WITH STENOSIS AFTER ESD WAS A WHITISH, SUPERFICIAL ELEVATED LESION EXTENDING FROM RB TO RA. IN THIS CASE, THE ANAL SIDE OF THE LESION WAS IN CONTACT WITH THE SQUAMOUS EPITHELIUM OF THE ANUS AND WAS SEEN CIRCUMFERENTIALLY. THE ORAL SIDE OF THE LESION HAD SPREAD TO RA FOR A MAXIMUM OF TWO-THIRDS. MARKING DOTS WERE PLACED WITH REFERENCE TO THE RESULTS OF THE PERIPHERAL BIOPSY DONE BEFORE ESD. ESD WAS PERFORMED CIRCUMFERENTIALLY ON THE ANAL SIDE AND INVOLVED THREE QUARTERS OF THE CIRCUMFERENCE ON THE ORAL SIDE. A TOTAL OF 6 ENDOSCOPIC BALLOON DILATIONS WERE PERFORMED FROM 69 TO 198 DAYS AFTER ESD. IN ANOTHER CASE, ESD WAS PERFORMED FOR A LESION WITH UNCLEAR MARGINS IN THE SIGMOID COLON. BECAUSE THE HORIZONTAL MARGIN WAS POSITIVE PATHOLOGICALLY, AN ADDITIONAL ESD PROCEDURE WAS PER FORMED 10 DAYS LATER. THIS PATIENT UNDERWENT FULL-CIRCUMFERENCE ESD THAT INCLUDED THE FIRST ESD ULCER. IN TOTAL, 3 ENDOSCOPIC BALLOON DILATATIONS WERE PERFORMED IN THE 27¿ 46 DAYS AFTER THE SECOND ESD. DURING A MEAN OBSERVATION PERIOD OF 28.5 MONTHS, THE LOCAL RECURRENCE RATE WAS 0%, THE SYNCHRONOUS TUMOR RATE WAS 25.0%, AND THE METACHRONOUS TUMOR RATE WAS 8.3%. THERE IS NO REPORT OF OLYMPUS DEVICE MALFUNCTION DESCRIBED IN THIS STUDY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED BY THE AUTHOR: THERE WAS NO MALFUNCTION OF THE OLYMPUS DEVICES AND THERE IS NO POSSIBILITY THAT AN OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233214 DISPOSABLE DISTAL ATTACHMENT DISPOSABLE DISTAL ATTACHMENT FDS OLYMPUS MEDICAL SYSTEMS CORP. D-201-11804 UNKNOWN(LITERATURE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other