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ShortShot G34063Recalls & reported problems

Cook Ireland Ltd · Shortshot Saeed Hemorrhoidal Multi-Band Ligator With Triview Anoscope · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Cook ShortShot hemorrhoidal band ligator is a hand-triggered device that places rubber bands around hemorrhoids to treat them. The 31 reports mostly describe the device failing to fire during a procedure, with bands snapping or not staying on the tissue, plus difficulty positioning the anoscope. There are no deaths and 1 injury. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
31
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00827002340633), received between Dec 21, 2016 and Sep 28, 2026 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 2 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Patient-Device Incompatibility13
  • Unintended Movement10
  • Difficult or Delayed Positioning3
  • Improper or Incorrect Procedure or Method3
  • No Apparent Adverse Event3
  • Suction Problem3
  • Use of Device Problem3
  • Activation Failure2

Patient problems

  • No Clinical Signs, Symptoms or Conditions16
  • No Known Impact Or Consequence To Patient15
  • No Consequences Or Impact To Patient5
  • No Code Available1

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 28, 2026Improper or Incorrect Procedure or Method

    On opening and utilizing 'short-shot', it was noted that only 2 rubber bands. Luckily there was another back up that was opened and used on the patient. The procedure was a success.______________________________Was the device expiry date checked prior to use of the device?> YesWas the device stored in its original packaging? > YesPlease describe the storage conditions especially pertaining to temperature and light exposure.> Product was used after it was delivered.Was the device tested prior to due by deploying a band? > NoWas the complaint issue identified prior to use? > No, it was identified during usage.Was alcohol applied to the device?> NoPlease describe the location and type of site to be banded.> Internal hemorrhoidsWere any other defects (other than the complaint issue) observed on the delivery system (e.g., kinks) prior to return?> NoAt what stage of the procedure was it first noted that only two rubber bands were present on the ShortShot device (e.g., during device preparation, upon insertion, or during the procedure)?> During the procedureWas an attempt made to deploy any of the bands before the issue was identified? If so, how many bands were successfully deployed, if

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50912843 ↗
  • MalfunctionJul 13, 2026Improper or Incorrect Procedure or Method

    DESCRIPTION OF EVENT EMAIL- THIS IS THE SAME DOCTOR THAT HAS PREVIOUS ISSUES AND RE-TRAINING, IT APPEARS, HE IS SPINNING THE THUMB WHEEL TO AGGRESSIVELY AND QUICKLY FOR IT TO ¿MISFIRE¿ THIS IS USER ERROR. COMPLAINT FORM- THE SHORTSHOT APPEARED TO MISS FIRE OF THE DURING HAEMORRHOID BANDING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25793479 ↗
  • MalfunctionJul 7, 2026Improper or Incorrect Procedure or Method

    MOST RECENT INCIDENTS WHICH OCCURRED ON 1ST APRIL. BOTH BANDING KITS MISFIRED DURING ANAL HEMORRHOID BANDING. USED THE SHORT SHOT SUCCESSFULLY WITH A DIFFERENT LOT C2384208. PATIENT/EVENT INFO - NOTES: WAS THE TRIGGER CORD WOUND ONTO THE HANDLE SPOOL UNTIL TAUT? YES WAS THE SPOOL ROTATED SLOWLY? I ASKED THE NURSES WHO WERE IN THE ROOM FOR FEEDBACK, THEY BELIEVED THE SPOOL WAS ROTATED FAST. HOW MANY BANDS WERE FIRED BEFORE THE ISSUE OCCURRED? BOTH NURSES DON'T KNOW HOW MANY BANDS DEPLOYED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25732237 ↗
  • MalfunctionApr 14, 2026Unintended Movement

    THE BANDS DEPLOYED BUT DID NOT REMAIN ON THE TISSUE. WAS THE DEVICE EXPIRY DATE CHECKED PRIOR TO USE OF THE DEVICE? YES- WITHIN EXPIRY DATE. EXPIRES ONLY 2026- 10-22. WAS THE DEVICE STORED IN ITS ORIGINAL PACKAGING? YES. PLEASE DESCRIBE THE STORAGE CONDITIONS ESPECIALLY PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. STORED IN THEATRE PHARMACY/STOCK ROOM. TEMPERATURE CONTROLLED/NO DIRECT SUNLIGHT. WAS THE DEVICE TESTED PRIOR TO DUE BY DEPLOYING A BAND? NO IF NOT WITH THE LIGATOR IN QUESTION, HOW WAS THE PROCEDURE FINISHED? A SECOND COOK LIGATOR WAS OPENED TO PERFORM THE PROCEDURE. IF ADDITIONAL INTERVENTION WAS PERFORMED, WAS IT DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SECOND DEVICE USED DURING SAME PROCEDURE- NO SECOND PROCEDURE REQUIRED. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TO RETURN? NO

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24874917 ↗
  • MalfunctionMay 29, 2025Retraction Problem; Unintended Movement; Retraction Problem; Unintended Movement

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 25-JUL-2025. 1. WAS GAINING ACCESS TO THE BANDING SITE DIFFICULT? YES, WITH THE ANOSCOPE PROVIDED - PAIN ON REMOVING OBTURATOR. INSERTION NOT PAINFUL BUT PAIN ELICITED ON REMOVAL OF OBTURATOR. ATTEMPTED DIFFERENT POSITIONING OF SLOTS. PT TOLERATED HILL-FERGUSON RETRACTOR BUT WAS UNABLE TO VISUALIZE HEMORRHOID. DID NOT ATTEMPT DEPLOYMENT OF BANDS. 2. WHAT MAKE & MODEL OF ENDOSCOPE WAS USED? AS ABOVE. 3. WERE THE VARICES SMALL IN SIZE? - MEDIUM. 1. IF NOT WITH THE LIGATOR IN QUESTION, HOW WAS THE PROCEDURE FINISHED? REFERRED OUT. 4. WHAT INTERVENTION (IF ANY) WAS REQUIRED? REFERRED OUT. 5. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A, SAME PROCEDURE, ANOTHER DAY. DID NOT ATTEMPT DEPLOYMENT OF BANDS DUE TO INTOLERANCE OF SCOPE. 6. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. RIGHT ANTERIOR. 7. WAS A DISPOSABLE CAP USED AT THE BIOPSY PORT? N/A, YES, NO (IF YES, PLEASE LIST THE CAP MANUFACTURER AND PART NUMBER) NA. 8. WAS SECURE ATTACHMENT OF DUETTE HANDLE SUCCESSFULLY ACCOMPLISHED AT BIOPSY PORT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22104399 ↗
  • MalfunctionJun 6, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

    WHILE POSITIONING THE SHORT SHOT BANDER INSIDE THE PATIENT AND AQUIRING THE HEMORRHOID, (B)(6) TRIED TO BAND THE TISSUE, BUT THE BAND SNAPPED, TRYING ALL FOUR BANDS WERE UNSUCCESSFUL, ALL FOUR SNAPPED WHILE TRYING TO BAND THE HEMORRHOID, THEY PULLED OUT ANOTHER SHORT SHOT BANDER TO USE ON THE PATIENT. PATIENT OUTCOME: DID ANY PIECE OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED (IF APPLICABLE): N/A. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)? NO PLEASE SPECIFY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: N/A PATIENT/EVENT INFO - NOTES: UPDATE RECEIVED FROM THE REP ON (B)(6)25 JIL01: ALL FOUR BANDS FAILED FROM THE ONE PRODUCT, ALL FOUR BANDS SNAPPED PRIOR TO BANDING THE TISSUE. THE SECOND SHORT SHOT THAT WAS USED WAS SUCCESSFUL, THIS IS WHY ONLY ONE COMPLAINT WAS RAISED FROM THIS DOCTOR AND HOSPITAL. WE ARE UNAWARE WHAT LOT# WAS SUCCESSFUL AS THIS WAS NOT RECORDED AS A COMPLAINT AND STOCK WAS USED FROM SHELF, AMONGST MANY OTHERS. PR383834-ALL FOUR BANDS WERE FROM THE ONE REPORTED BANDER ((B)(6)2023) ALL FOUR BANDS WERE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17071399 ↗
  • MalfunctionApr 4, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

    THE REP REPORTED A COMPLAINT FROM RESERVOIR PRIVATE REGARDING 4 X SHORTSHOT (HMBL-4-TRI) FAILING TO ENGAGE. LOT NUMBERS: 1 X C19665 (REP ASKED TO CONFIRM LOT) - (B)(4). 1 X C1962064 -(B)(4). 1 X C19634 (REP ASKED TO CONFIRM LOT) - (B)(4). 1X C1966535 - (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16673710 ↗
  • MalfunctionApr 4, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

    THE REP REPORTED A COMPLAINT FROM RESERVOIR PRIVATE REGARDING 4 X SHORTSHOT (HMBL-4-TRI) FAILING TO ENGAGE. LOT NUMBERS: 1 X C19665 (REP ASKED TO CONFIRM LOT) - (B)(4). 1 X C1962064 - (B)(4). 1 X C19634 (REP ASKED TO CONFIRM LOT) - (B)(4). 1X C1966535 - (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16673670 ↗
  • MalfunctionDec 20, 2022Patient-Device Incompatibility; Unintended Movement; No Apparent Adverse Event; Patient-Device Incompatibility; Unintended Movement; No Apparent Adverse Event

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION FROM THE LAB EVALUATION ON THE 25 JAN 2023.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16014934 ↗
  • MalfunctionMar 24, 2022Defective Device; Unintended Movement; Defective Device; Unintended Movement

    USER UTILIZED THE DEVICE TO SUCK THE HEMORRHOIDS INTO BARRELM, THEN ROTATE THE HANDLE TO RELEASE THE BAND BUT FOUND OUT THE BAND DOESN'T SHRINK AS EXPECTED. USER THEN UTILIZED A THREAD TO COMPLETE THE LIGATION. USER TOOK A DEVICE FROM SAME LOT# AFTER PROCEDURE AND RELEASE THE BAND TO CONFIRM THE BANDS FUNCTION AND FOUND OUT THE BAND DOESN'T SHRINK EITHER. VIDEO ATTACHED LAB EVALUATION COMPLETE ON 11MARCH2022: VISUAL INSPECTION: ALL 3 BANDS RETURNED ALL BANDS DEPLOYED. THREAD IS TRACKED ON SPOOL AS IS EXPECTED. FUNCTIONAL INSPECTION SPOOL ROTATES AS EXPECTED. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13886078 ↗
  • MalfunctionJun 16, 2021Patient-Device Incompatibility; Activation, Positioning or Separation Problem; Patient-Device Incompatibility; Activation, Positioning or Separation Problem

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12009766 ↗
  • MalfunctionJun 11, 2021Biocompatibility; Activation, Positioning or Separation Problem; Biocompatibility; Activation, Positioning or Separation Problem

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11981275 ↗
  • MalfunctionDec 4, 2020Unintended Movement; Activation Failure; Unintended Movement; Activation Failure

    THIS IS A FINAL REPORT. THE INVESTIGATION WAS COMPLETED ON 13-APR-21. RESULTS AND CONCLUSIONS ARE OUTLINED IN SECTION OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 10945451 ↗
  • MalfunctionDec 4, 2020Unintended Movement; Activation Failure; Unintended Movement; Activation Failure

    THIS IS A FINAL REPORT. THE INVESTIGATION WAS COMPLETED ON 13-APR-21. RESULTS AND CONCLUSIONS ARE OUTLINED IN SECTION H OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 10945397 ↗
  • MalfunctionJun 4, 2020Patient-Device Incompatibility; Unintended Movement; Patient-Device Incompatibility; Unintended Movement

    USER SUCKED THE HEMORRHOIDS IN PLACE AND ROTATED THE SPOOL RELEASING THE BAND, BUT THE BAND HAS NO ELASTICITY. BAND DIDN'T SHRINK. USER CHANGED A DOMESTIC BRAND OF SIMILAR DEVICE TO COMPLETE THE PROCEDURE. USER HAS CONCERNS OF REST OF UNUSED PRODUCT ON HAND AND FILE THE COMPLAINT TO RETURN THE PRODUCT. PRIOR TO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 10121183 ↗
  • MalfunctionMay 26, 2020Patient-Device Incompatibility; Unintended Movement; Patient-Device Incompatibility; Unintended Movement

    FINAL MDR BEING SUBMITTED BASED ON COMPLETION OF INVESTIGATION ON 30-JUL-21.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 10087885 ↗
  • MalfunctionMay 26, 2020Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

    THIS IS A CANCELLATION REPORT. THE INVESTIGATION WAS COMPLETED ON 03-NOV-2020 AND THIS COMPLAINT HAS BEEN CATEGORIZED AS NEGATIVE FEEDBACK AND THEREFORE, DOES NOT MEET THE REPORTING CRITERIA AS PER REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016). PLEASE REFER TO G AND H FOR DETAILS OF THE INVESTIGATION.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 10087879 ↗
  • MalfunctionMay 22, 2020Unintended Movement; No Apparent Adverse Event; Unintended Movement; No Apparent Adverse Event

    SUPPLEMENTAL REPORT BEING SUBMITTED FOLLOWING COMPLETION OF INVESTIGATION. THE RUBBER BANDS WERE SO LOOSEN SO THEY COULD NOT BAND THE HEMORRHOIDS TIGHTLY. (PR (B)(4)). PHYSICIAN USED ANOTHER NEW HBML-4-TRI, BUT HE FELT THAT THE BANDING WAS NOT AS TIGHT AS THE PAST (THIS COMPLAINT).

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 10081877 ↗
  • MalfunctionMay 22, 2020Unintended Movement; Unintended Movement

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION. THE RUBBER BANDS WERE SO LOOSEN SO THEY COULD NOT BAND THE HEMORRHOIDS TIGHTLY. PHYSICIAN USED ANOTHER NEW HBML-4-TRI, BUT HE FELT THAT THE BANDING WAS NOT AS TIGHT AS THE PAST.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10081837 ↗
  • MalfunctionAug 8, 2019Difficult or Delayed Positioning; Suction Problem; Difficult or Delayed Positioning; Suction Problem

    AS REPORTED TO CUSTOMER RELATIONS: "CUSTOMER REPORTED HEMORRHOID BANDER ISSUES TO [DM]. CUSTOMER AND DM BELIEVE, BASED ON USAGE, THAT IT IS A SUCTION ISSUE WITH THE "CAP"; WHEN THEY GO TO DEPLOY A BAND THE BAND SLIPS OFF THE HEMORRHOID. PROCEDURES WERE ALL COMPLETED WITH ADDITIONAL DEVICES FROM THE SAME GPN."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8873611 ↗
  • MalfunctionAug 8, 2019Difficult or Delayed Positioning; Suction Problem; Difficult or Delayed Positioning; Suction Problem

    AS REPORTED TO CUSTOMER RELATIONS, "CUSTOMER REPORTED HEMORRHOID BANDER ISSUES TO [DM]. CUSTOMER AND DM BELIEVE, BASED ON USAGE, THAT IT IS A SUCTION ISSUE WITH THE "CAP"; WHEN THEY GO TO DEPLOY A BAND THE BAND SLIPS OFF THE HEMORRHOID. PROCEDURES WERE ALL COMPLETED WITH ADDITIONAL DEVICES FROM THE SAME GPN."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8873571 ↗
  • MalfunctionAug 8, 2019Difficult or Delayed Positioning; Suction Problem; Difficult or Delayed Positioning; Suction Problem

    AS REPORTED TO CUSTOMER RELATIONS: "CUSTOMER REPORTED HEMORRHOID BANDER ISSUES TO [DM]. CUSTOMER AND DM BELIEVE, BASED ON USAGE, THAT IT IS A SUCTION ISSUE WITH THE "CAP"; WHEN THEY GO TO DEPLOY A BAND THE BAND SLIPS OFF THE HEMORRHOID. PROCEDURES WERE ALL COMPLETED WITH ADDITIONAL DEVICES FROM THE SAME GPN."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8873554 ↗
  • MalfunctionJul 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    AS REPORTED TO CUSTOMER RELATIONS: "CUSTOMER REPORTED HEMORRHOID BANDER ISSUES TO [DM]. CUSTOMER AND DM BELIEVE, BASED ON USAGE, THAT IT IS A SUCTION ISSUE WITH THE "CAP"; WHEN THEY GO TO DEPLOY A BAND THE BAND SLIPS OFF THE HEMORRHOID. PROCEDURES WERE ALL COMPLETED WITH ADDITIONAL DEVICES FROM THE SAME GPN."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8816213 ↗
  • MalfunctionJul 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    AS REPORTED TO CUSTOMER RELATIONS: "CUSTOMER REPORTED HEMORRHOID BANDER ISSUES TO [DM]. CUSTOMER AND DM BELIEVE, BASED ON USAGE, THAT IT IS A SUCTION ISSUE WITH THE "CAP"; WHEN THEY GO TO DEPLOY A BAND THE BAND SLIPS OFF THE HEMORRHOID. PROCEDURES WERE ALL COMPLETED WITH ADDITIONAL DEVICES FROM THE SAME GPN."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8816179 ↗
  • MalfunctionJul 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    AS REPORTED TO CUSTOMER RELATIONS: "CUSTOMER REPORTED HEMORRHOID BANDER ISSUES TO [DM]. CUSTOMER AND DM BELIEVE, BASED ON USAGE, THAT IT IS A SUCTION ISSUE WITH THE "CAP"; WHEN THEY GO TO DEPLOY A BAND THE BAND SLIPS OFF THE HEMORRHOID. PROCEDURES WERE ALL COMPLETED WITH ADDITIONAL DEVICES FROM THE SAME GPN."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8816114 ↗

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