BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 7876517 · Received September 14, 2018

    Report

    Report Number
    1037905-2018-00419
    Event Type
    Injury
    Date Received
    September 14, 2018
    Report Date
    August 22, 2018
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    WAI, C. T., HO, K. Y., & KWOK, F. Y. (2003). ESOPHAGEAL DISLODGMENT OF A VARICEAL LIGATOR CAP DUE TO SIZE MISMATCH BETWEEN THE LIGATOR CAP AND THE ENDOSCOPE. ENDOSCOPY, 35(2), 191-191. DOI:10.1055/S-2003-37005 CORRECTION TO SECTION B1: THIS REPORT IS BEING SENT TO CORRECT B1:ADVERSE EVENT AND/OR PRODUCT PROBLEM FROM ADVERSE EVENT TO ADVERSE EVENT AND PRODUCT PROBLEM. CORRECTION TO SECTION B2: THIS REPORT IS BEING SENT TO CORRECT B2: OUTCOMES ATTRIBUTED TO ADVERSE EVENT FROM BLANK TO REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE (DEVICES). CONTINUED FROM SECTION B3: 2003 INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. A PHOTO WAS PROVIDED AND REVIEWED. AN EVALUATION OF THE PHOTO PROVIDED CONFIRMED THE REPORT. THE PHOTO PROVIDED SHOWS THE ENDOSCOPIC VIEW OF THE DETACHED BARREL IN THE ESOPHAGUS. WITHOUT RETURN OF THE COMPLAINT DEVICE A COMPLETE EVALUATION COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED COULD NOT BE REVIEWED BECAUSE A LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: THE ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ENDOSCOPE USED WAS AN OLYMPUS GIF XQ240. ON RESEARCHING THE ENDOSCOPE USED, IT WAS DETERMINED THAT OLYMPUS GIF XQ240 HAS AN OUTER DIAMETER THAT IS 9.0 MM WHICH IS OUTSIDE THE RECOMMENDED ENDOSCOPE DIAMETER. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT INSTRUCT THE USER TO REFER TO THE PRODUCT PACKAGE LABEL FOR USE OF THE APPROPRIATE ENDOSCOPE WITH THE FOLLOWING: "REFER TO PACKAGE LABEL FOR MINIMUM CHANNEL SIZE REQUIRED FOR THIS DEVICE." THE MBL-6 IS COMPATIBLE WITH ENDOSCOPES THAT HAVE AN OUTER DIAMETER OF 9.5 MM - 13 MM. USE OF THE DEVICE WITH AN INCOMPATIBLE ENDOSCOPE IS THE MOST LIKELY CAUSE FOR THE REPORTED OBSERVATION. PRIOR TO DISTRIBUTION, ALL 6 SHOOTER SAEED MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. "WE DESCRIBE A CASE OF DISLODGMENT OF THE LIGATOR CAP [BARREL] IN A PATIENT WITHOUT ESOPHAGEAL STRICTURE. . . ENDOSCOPY USING AN OLYMPUS GASTROSCOPE GIF XQ240 SHOWED FOUR CORDS OF GRADE II ESOPHAGEAL VARICES. THE GASTROSCOPE WAS WITHDRAWN, LOADED WITH A VARICEAL LIGATOR (SIX-SHOOTERS S MBL-6; WILSON-COOK MEDICAL, WINSTON-SALEM, NORTH CAROLINA, USA) AND EVL WAS PERFORMED. HOWEVER, UPON WITHDRAWAL OF THE ENDOSCOPE, THE LIGATOR CAP FELL FROM THE ENDOSCOPE AND BECAME LODGED IN THE MID-ESOPHAGUS. THE CAP WAS RETRIEVED WITH RAT-TOOTH FORCEPS WITHOUT COMPLICATION. . . AT OUR ENDOSCOPY UNIT, WE HAVE BEEN USING THE OLYMPUS GASTROSCOPE GIF XQ230 (EXTERNAL DIAMETER 9.2 MM) SINCE 1996 AND THE GIF XQ240 (EXTERNAL DIAMETER 9.0 MM) SINCE THE YEAR 2000. WITH THE PHASING OUT OF THE XQ230 MODEL, MOST OF THE UPPER ENDOSCOPES IN OUR UNIT ARE NOW THE SLIMMER XQ240 MODEL, WHOSE DIAMETER IS SMALLER THAN THE RECOMMENDED FITTING DIAMETER FOR THE DISTAL CAP OF THE MBL-6 OF 9.5 TO 13.0 MM. THE SIZE MISMATCH CAUSED DISLODGMENT OF THE LIGATOR CAP. WE REPORTED THE INCIDENT TO THE SUPPLIER OF THE LIGATORS AND WE HAVE SINCE BEEN SUPPLIED WITH MBL-6-XS LIGATORS, WHOSE DISTAL CAPS FIT SCOPES WITH A DIAMETER OF 8.6 MM TO 9.2 MM. WE RECOMMEND CAREFUL CHECKING OF THE ENDOSCOPE DIAMETER AND MATCHING IT WITH THE CORRECT SIZE OF LIGATOR CAP BEFORE PERFORMING VARICEAL LIGATION, IN ORDER TO AVOID SUCH A COMPLICATION." BASED ON THE CLINICAL CASE REPORT, AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT REQUIRED THE LIGATOR CAP (BARREL) TO BE RETRIEVED WITH RAT-TOOTH FORCEPS WITHOUT COMPLICATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Additional Manufacturer Narrative · 1

    WAI, C. T., HO, K. Y., & KWOK, F. Y. (2003). ESOPHAGEAL DISLODGMENT OF A VARICEAL LIGATOR CAP DUE TO SIZE MISMATCH BETWEEN THE LIGATOR CAP AND THE ENDOSCOPE. ENDOSCOPY, 35(2), 191-191. DOI:10.1055/S-2003-37005. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. A PHOTO WAS PROVIDED AND REVIEWED. AN EVALUATION OF THE PHOTO PROVIDED CONFIRMED THE REPORT. THE PHOTO PROVIDED SHOWS THE ENDOSCOPIC VIEW OF THE DETACHED BARREL IN THE ESOPHAGUS. WITHOUT RETURN OF THE COMPLAINT DEVICE A COMPLETE EVALUATION COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED COULD NOT BE REVIEWED BECAUSE A LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: THE ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ENDOSCOPE USED WAS AN OLYMPUS GIF XQ240. ON RESEARCHING THE ENDOSCOPE USED, IT WAS DETERMINED THAT OLYMPUS GIF XQ240 HAS AN OUTER DIAMETER THAT IS 9.0 MM WHICH IS OUTSIDE THE RECOMMENDED ENDOSCOPE DIAMETER. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT INSTRUCT THE USER TO REFER TO THE PRODUCT PACKAGE LABEL FOR USE OF THE APPROPRIATE ENDOSCOPE WITH THE FOLLOWING: "REFER TO PACKAGE LABEL FOR MINIMUM CHANNEL SIZE REQUIRED FOR THIS DEVICE." THE MBL-6 IS COMPATIBLE WITH ENDOSCOPES THAT HAVE AN OUTER DIAMETER OF 9.5 MM - 13 MM. USE OF THE DEVICE WITH AN INCOMPATIBLE ENDOSCOPE IS THE MOST LIKELY CAUSE FOR THE REPORTED OBSERVATION. PRIOR TO DISTRIBUTION, ALL 6 SHOOTER SAEED MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. [(B)(4)].

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. WE DESCRIBE A CASE OF DISLODGMENT OF THE LIGATOR CAP [BARREL] IN A PATIENT WITHOUT ESOPHAGEAL STRICTURE. ENDOSCOPY USING AN OLYMPUS GASTROSCOPE GIF XQ240 SHOWED FOUR CORDS OF GRADE II ESOPHAGEAL VARICES. THE GASTROSCOPE WAS WITHDRAWN, LOADED WITH A VARICEAL LIGATOR (SIX-SHOOTERS S MBL-6; (B)(6) MEDICAL, (B)(6), USA) AND EVL WAS PERFORMED. HOWEVER, UPON WITHDRAWAL OF THE ENDOSCOPE, THE LIGATOR CAP FELL FROM THE ENDOSCOPE AND BECAME LODGED IN THE MID-ESOPHAGUS. THE CAP WAS RETRIEVED WITH RAT-TOOTH FORCEPS WITHOUT COMPLICATION. AT OUR ENDOSCOPY UNIT, WE HAVE BEEN USING THE OLYMPUS GASTROSCOPE GIF XQ230 (EXTERNAL DIAMETER 9.2 MM) SINCE 1996 AND THE GIF XQ240 (EXTERNAL DIAMETER 9.0 MM) SINCE THE YEAR 2000. WITH THE PHASING OUT OF THE XQ230 MODEL, MOST OF THE UPPER ENDOSCOPES IN OUR UNIT ARE NOW THE SLIMMER XQ240 MODEL, WHOSE DIAMETER IS SMALLER THAN THE RECOMMENDED FITTING DIAMETER FOR THE DISTAL CAP OF THE MBL-6 OF 9.5 TO 13.0 MM. THE SIZE MISMATCH CAUSED DISLODGMENT OF THE LIGATOR CAP. WE REPORTED THE INCIDENT TO THE SUPPLIER OF THE LIGATORS AND WE HAVE SINCE BEEN SUPPLIED WITH MBL-6-XS LIGATORS, WHOSE DISTAL CAPS FIT SCOPES WITH A DIAMETER OF 8.6 MM TO 9.2 MM. WE RECOMMEND CAREFUL CHECKING OF THE ENDOSCOPE DIAMETER AND MATCHING IT WITH THE CORRECT SIZE OF LIGATOR CAP BEFORE PERFORMING VARICEAL LIGATION, IN ORDER TO AVOID SUCH A COMPLICATION. BASED ON THE CLINICAL CASE REPORT, AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT REQUIRED THE LIGATOR CAP (BARREL) TO BE RETRIEVED WITH RAT-TOOTH FORCEPS WITHOUT COMPLICATION. FURTHER INFORMATION ON THE PATIENT OUTCOME IS NOT AVAILABLE AS THE INFORMATION PROVIDED IS FROM A CLINICAL CASE REPORT BASED ON THE RECORD OF A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719667 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention OLYMPUS ENDOSCOPE - GIF XQ240| OLYMPUS ENDOSCOPE - GIF XQ240