Single Use Repositionable ClipRecalls & reported problems across all models

We found 7 models of Single Use Repositionable Clip by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 248 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2018 and Feb 13, 2026 — classified as 79 injuries, 169 malfunctions.

The most frequently reported specific device problem is “Break” (37 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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 Repositionable Clip 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. May 4, 2023Open, Classified

   Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

   Z-1990-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 4, 2023Open, Classified

   Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

   Z-1989-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. May 4, 2023Open, Classified

   Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

   Z-1988-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. May 4, 2023Open, Classified

   Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

   Z-1987-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Single Use Repositionable Clip problems

Single Use Repositionable Clip models

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

• Single Use Repositionable Clip HX-202UR

  Hemostatic metal clip for the GI tract
  1 recall118 reports
• Single Use Repositionable Clip HX-202UR

  Hemostatic metal clip for the GI tract
  87 reports
• Single Use Repositionable Clip HX-202UR

  Hemostatic metal clip for the GI tract
  1 recall23 reports
• Single Use Repositionable Clip HX-202LR

  Hemostatic metal clip for the GI tract
  1 recall2 reports
• Single Use Repositionable Clip HX-202LR

  Hemostatic metal clip for the GI tract
  1 recall0 reports
• Single Use Repositionable Clip HX-202UR

  Hemostatic metal clip for the GI tract
  15 reports
• Single Use Repositionable Clip HX-202LR

  Hemostatic metal clip for the GI tract
  3 reports

Recent Single Use Repositionable Clip adverse event reports

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

• MalfunctionFeb 13, 2026Difficult to Open or Close

  IT WAS REPORTED THE SINGLE USE REPOSITIONAL CLIP GOT STUCK AND THERE WAS NO WAY TO RELEASE IT. THE ISSUE OCCURRED DURING A THERAPEUTIC GASTROSCOPY AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333120 ↗
• MalfunctionAug 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 22902766 ↗
• MalfunctionMay 22, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE, THE SUBJECT DEVICE FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE AND THERE WERE NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074917 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107358 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED : (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107345 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107272 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107262 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107245 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107213 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106906 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED : (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106697 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106544 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106535 ↗
• InjurySep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ONCE THE CLIP DELIVERY SYSTEM WENT THROUGH THE SCOPE AND INTO THE COLON, THE CLIP JUST FELL OFF THE DELIVERY SYSTEM WITHOUT DEPLOYING THE CLIP. THE CUSTOMER LATER REPORTED THAT THE CLIP FELL INTO THE PATIENT AND WAS RECOVERED WITHOUT ANY INJURY OR HARM. THE PROCEDURE BEING PERFORMED WAS A COLONOSCOPY, WHICH WAS COMPLETED SUCCESSFULLY WITH A COMPETITOR PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20252788 ↗
• MalfunctionSep 11, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, THE SINGLE USE REPOSITIONABLE CLIP TOOK FORCE TO PLACE THE ENDOCLIP. BUT THEN, THE ENDOCLIP COULD NOT BE DETACHED FROM THE BASE. THE ISSUE OCCURRED, DURING A GASTROSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20187160 ↗

Other Olympus Medical Systems Corp. products

• EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
• EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
• EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
• EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
• EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
• EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
• HD CAMERA HEAD2 models · 5,217 reports