Single Use Rotatable Clip Fixing DeviceRecalls & reported problems across all models

We found 9 models of Single Use Rotatable Clip Fixing Device by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2018 and Apr 5, 2024 — classified as 1 death, 13 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (7 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Single Use Rotatable Clip Fixing Device recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 23, 2023Open, Classified

   There have been complaints that the clip did not come out of the tube sheath during the procedure.

   Z-1418-2023 · Root cause: Process change control · names 4 of these models · Recall details · FDA record ↗

Most reported Single Use Rotatable Clip Fixing Device problems

Single Use Rotatable Clip Fixing Device models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Single Use Rotatable Clip Fixing Device HX-201UR-135

  Ligator, esophageal
  1 recall1 death10 reports
• Single Use Rotatable Clip Fixing Device HX-201UR-135L

  Ligator, esophageal
  1 recall8 reports
• Single Use Rotatable Clip Fixing Device HX-201LR-135

  Ligator, esophageal
  1 recall0 reports
• Single Use Rotatable Clip Fixing Device HX-201UR-135

  Ligator, esophageal
  1 recall0 reports
• Single Use Rotatable Clip Fixing Device HX-201UR-135

  Ligator, esophageal
  3 reports
• Single Use Rotatable Clip Fixing Device HX-201UR-135

  Ligator, esophageal
  3 reports
• Single Use Rotatable Clip Fixing Device HX-201LR-135L

  Ligator, esophageal
  2 reports
• Single Use Rotatable Clip Fixing Device HX-201LR-135

  Ligator, esophageal
  1 report
• Single Use Rotatable Clip Fixing Device HX-201YR-135

  Ligator, esophageal
  1 report

Recent Single Use Rotatable Clip Fixing Device adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION OF AN OLYMPUS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 19053566 ↗
• MalfunctionFeb 2, 2024Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED TO OLYMPUS EZCLIP DIDN¿T GET LOOSE AFTER ATTACHING TO THE COLON CLOSING THE FORCEPS (WERE AT THE HIGHEST POINT IN THE COLON). THE USER HAD TO OPEN AND CLOSE SEVERAL TIMES. THE INTENDED PROCEDURE WAS COLONOSCOPY POLYP REMOVAL AND WAS COMPLETED WITH ANOTHER EZCLIP. THE PATIENT WAS NOT UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630750 ↗
• InjuryOct 20, 2023Break; Unintended System Motion; Detachment of Device or Device Component; Break; Unintended System Motion; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE, AND IN TURN, THE PATIENT'S ANESTHESIA, WERE EXTENDED FOR AN UNKNOWN DURATION DUE TO THE NEED TO USE ANOTHER DEVICE TO SOLVE THE ISSUE. THE CUSTOMER ALSO NOTED THAT THERE WAS "BREAKAGE AND/OR FALL OF ANY FRAGMENT IN ANY CAVITY OF THE PATIENT" DURING THE USE OF THE DEVICE, WHICH WAS OBSERVED AT THE INITIAL POINT OF THE PROCEDURE. THERE WERE NO REPORTS OF ANY UNEXPECTED BLEEDING DURING THE PROCEDURE AND NO NEED FOR LONGER HOSPITALIZATION OR SURGERY DUE TO AVAILABILITY OF OTHER TYPES OF ENDOCLIPS WITH MORE EFFICIENT FUNCTIONING AS WELL AS OTHER TECHNIQUES ENDOSCOPISTS USE TO AVOID THIS OUTCOME. THE CUSTOMER INDICATED THAT THE PROCEDURE WAS NOT COMPLETED. HOWEVER, AN OLYMPUS REPRESENTATIVE REPORTED THAT THE PROCEDURE HAD TO BE COMPLETED WITH ANOTHER DEVICE. THERE WAS NO FURTHER PATIENT IMPACT REPORTED. AN OLYMPUS PRODUCT SPECIALIST ALSO COMMENTED THAT THE CUSTOMER WAS NOT USED TO THIS PRODUCT AND DID NOT REQUEST TRAINING. CONSEQUENTLY, THE PHYSICIAN HAS BEEN CONTACTED FOR TRAINING. ADDITIONAL INFORMATION HAS BEEN REQUESTED CLARIFYING THE EVENT DETAILS; HOWEVER, NO FURTHER INFORMATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981123 ↗
• MalfunctionJul 11, 2023Ejection Problem; Ejection Problem

  A CUSTOMER REPORTED TO OLYMPUS DURING A THERAPEUTIC COLONOSCOPY, THE SINGLE USE ROTATABLE CLIP FIXING DEVICE WOULD NOT DEPLOY PROPERLY FROM THE INSERTION WIRE WHEN TRIGGER WAS PULLED. THE CLIP DID NOT ATTACH TO THE TISSUE AT THE TREATMENT SITE. A SECOND CLIP FELL OFF INTO THE SCOPE CHANNEL. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297551 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR CONFIRMS THERE WERE NO OLYMPUS DEVICE MALFUNCTION AND NO OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO ANY OF THE PATIENT ADVERSE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Unspecified Tissue Injury

  MAUDE report 16938970 ↗
• InjuryNov 18, 2022Break; Break

  THE CUSTOMER REPORTED, DURING AN (B)(6) 2022 THERAPEUTIC EMERGENCY PROCEDURE TO CONTROL BLEEDING, FOR A BLEEDING BULBAR ULCER, THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING WITH THE OLYMPUS CLIPS BUT TWO CLIPS FAILED TWICE AND DID NOT COME OUTSIDE OF THE SHEATH. THE SURGEON CONTROLLED THE ACTIVE BLEEDING BY INJECTING ADRENALINE AND SCLEROSANT (LAUROMACROGOL). THE PATIENT WAS TRANSFERRED TO A LEVEL 2 ENDOSCOPY FACILITY WITH EMERGENCY SERVICE AS A PRECAUTIONARY MEASURE TO MAKE SURE THE PATIENT RECEIVED THE MOST APPROPRIATE SERVICE. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO DAMAGES IDENTIFIED. THE CUSTOMER RETURNED 2 CLIPS AND CONFIRMED THE 2 CLIPS FAILED TO DEPLOY OUTSIDE THE SHEATH DURING THIS SAME PROCEDURE. THIS EVENT INCLUDES 2 REPORTS: (B)(6): CLIP 1. (B)(6): CLIP 2. THIS REPORT IS 2 OF 2 FOR (B)(6): CLIP 2.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15828388 ↗
• InjuryOct 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED, DURING AN (B)(6) 2022 THERAPEUTIC EMERGENCY PROCEDURE TO CONTROL BLEEDING FOR A BLEEDING BULBAR ULCER, THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING WITH THE SUBJECT DEVICE BUT IT FAILED. THE SURGEON CONTROLLED THE ACTIVE BLEEDING BY INJECTING ADRENALINE AND SCLEROSANT (LAUROMACROGOL). THE PATIENT WAS TRANSFERRED TO A LEVEL 2 ENDOSCOPY FACILITY WITH EMERGENCY SERVICE AS A PRECAUTIONARY MEASURE TO MAKE SURE THE PATIENT RECEIVED THE MOST APPROPRIATE SERVICE. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO DAMAGES IDENTIFIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15690956 ↗
• MalfunctionAug 4, 2022Separation Failure; Activation, Positioning or Separation Problem; Separation Failure; Activation, Positioning or Separation Problem

  CUSTOMER REPORTED AN OUT OF BOX FAILURES FOR THREE HX-201UR-135-A DEVICE WITH LOT NUMBER 17V 01 . DEVICE WAS REPORTED TO FAIL UPON INITIAL USE (THERAPEUTIC). THE QUICKCLIPS WOULD ATTACH TO TISSUE, BUT WOULD NOT DETACH FROM THE WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS EVENT INCLUDES THREE (3) REPORTS TO ACCOUNT THE THREE DEVICES FAILED THAT CUSTOMER REPORTED. REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15171912 ↗
• MalfunctionAug 4, 2022Separation Failure; Activation, Positioning or Separation Problem; Separation Failure; Activation, Positioning or Separation Problem

  CUSTOMER REPORTED AN OUT OF BOX FAILURES FOR THREE HX-201UR-135-A DEVICE WITH LOT NUMBER: 17V 01 . DEVICE WAS REPORTED TO FAIL UPON INITIAL USE (THERAPEUTIC). THE QUICKCLIPS WOULD ATTACH TO TISSUE, BUT WOULD NOT DETACH FROM THE WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS EVENT INCLUDES THREE (3) REPORTS TO ACCOUNT THE THREE DEVICES FAILED THAT CUSTOMER REPORTED. REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15171798 ↗
• MalfunctionAug 4, 2022Separation Failure; Activation, Positioning or Separation Problem; Separation Failure; Activation, Positioning or Separation Problem

  CUSTOMER REPORTED AN OUT OF BOX FAILURES FOR THREE HX-201UR-135-A DEVICE WITH LOT NUMBER 17V 01 . DEVICE WAS REPORTED TO FAIL UPON INITIAL USE (THERAPEUTIC). THE QUICKCLIPS WOULD ATTACH TO TISSUE, BUT WOULD NOT DETACH FROM THE WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS EVENT INCLUDES THREE (3) REPORTS TO ACCOUNT THE THREE DEVICES FAILED THAT CUSTOMER REPORTED. REPORT WITH PATIENT IDENTIFIER (B)(6), REPORT WITH PATIENT IDENTIFIER (B)(6), REPORT WITH PATIENT IDENTIFIER (B)(6), THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15171650 ↗
• MalfunctionAug 3, 2022Separation Failure; Activation, Positioning or Separation Problem; Separation Failure; Activation, Positioning or Separation Problem

  CUSTOMER REPORTED AN OUT OF BOX FAILURES FOR THREE HX-201UR-135-A DEVICE WITH LOT NUMBER 17V 01 . DEVICE WAS REPORTED TO FAIL UPON INITIAL USE (THERAPEUTIC). THE QUICKCLIPS WOULD ATTACH TO TISSUE, BUT WOULD NOT DETACH FROM THE WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS EVENT INCLUDES THREE REPORTS TO ACCOUNT THE THREE DEVICES FAILED THAT CUSTOMER REPORTED. REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161619 ↗
• MalfunctionAug 3, 2022Separation Failure; Activation, Positioning or Separation Problem; Separation Failure; Activation, Positioning or Separation Problem

  CUSTOMER REPORTED AN OUT OF BOX FAILURES FOR THREE HX-201UR-135-A DEVICE WITH LOT NUMBER 17V 01 . DEVICE WAS REPORTED TO FAIL UPON INITIAL USE (THERAPEUTIC). THE QUICKCLIPS WOULD ATTACH TO TISSUE, BUT WOULD NOT DETACH FROM THE WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS EVENT INCLUDES THREE (3) REPORTS TO ACCOUNT THE THREE DEVICES FAILED THAT CUSTOMER REPORTED. REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161610 ↗
• MalfunctionAug 3, 2022Separation Failure; Activation, Positioning or Separation Problem; Separation Failure; Activation, Positioning or Separation Problem

  CUSTOMER REPORTED AN OUT OF BOX FAILURES FOR THREE HX-201UR-135-A DEVICE WITH LOT NUMBER 17V 01 . DEVICE WAS REPORTED TO FAIL UPON INITIAL USE (THERAPEUTIC). THE QUICKCLIPS WOULD ATTACH TO TISSUE, BUT WOULD NOT DETACH FROM THE WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS EVENT INCLUDES THREE (3) REPORTS TO ACCOUNT THE THREE DEVICES FAILED THAT CUSTOMER REPORTED. REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161603 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "ENDOSCOPIC FULL-THICKNESS RESECTION VERSUS ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE TREATMENT OF COLONIC NEOPLASTIC LESIONS = 30 MM¿A SINGLE-CENTER EXPERIENCE."    LITERATURE SUMMARY. THE PURPOSE OF THE ANALYSIS WAS TO EVALUATE EFFICACY AND SAFETY OF FULL-THICKNESS RESECTION (FTR) IN THE TREATMENT OF COLORECTAL LESIONS = 30 MM BY COMPARING PROSPECTIVELY FOLLOWED FTR COHORT TO RETROSPECTIVE SUBMUCOSAL DISSECTION (ESD) COHORT IN THE SETTING OF SINGLE TERTIARY ENDOSCOPY CENTER. PRIMARY OUTCOMES WERE TECHNICAL SUCCESS RATE, R0 RESECTION AND CURATIVE RESECTION RATE, AND COMPLICATION RATE. A TOTAL OF 52 PATIENTS IN FTR AND 50 PATIENTS IN ESD GROUP WERE TREATED BETWEEN 2015 AND 2018. TECHNICAL SUCCESS RATE WAS SIGNIFICANTLY HIGHER IN FTR GROUP (92 VS. 74%, P = 0.01) AS WELL AS R0 RESECTION RATE (85 VS. 62%, P = 0.01) AND CURATIVE RESECTION RATE (75 VS. 56%, P = 0.01). COMPLICATIONS OCCURRED MORE FREQUENTLY IN ESD GROUP (40 VS. 13%, P = 0.002), MAINLY DUE TO HIGH INCIDENCE OF ELECTROCOAGULATION SYNDROME (24 VS. 0%). TOTAL PROCEDURE TIME WAS SUBSTANTIALLY SHORTER IN FTR GROUP (26.4 ± 11.0 MIN VS. ESTIMATED 90¿240 MIN). LOCAL RESIDUAL NEOPLASTIC LES

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14856720 ↗
• MalfunctionJun 10, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC POLYPECTOMY PROCEDURE WHILE ATTEMPTING TO CLOSE THE SITE POST POLYPECTOMY, THE DEVICE WAS CLOSED ONTO THE TISSUE. HOWEVER, THE DEVICE CLIP WAS NOT ABLE TO RELEASE AND BE DEPLOYED. THE DRIVE WIRE INSIDE THE HANDLE WAS BUCKLING OUT OF THE HANDLE. THE CLIP HAD TO BE REMOVED BY FORCE FROM THE TISSUE AND THE DEVICE REMOVED. THE PROCEDURE WAS COMPLETED BY USING DEVICE FROM MIROCTECH BRAND. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE PATIENT OUTCOME WAS NORMAL AND AS EXPECTED. CUSTOMER REQUEST A REPLACEMENT OF THE ENTIRE BATCH OF THE DEVICE OWNED BY THE CUSTOMER WITH DEVICES FROM OTHER BATCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655846 ↗

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