DISPOSABLE DISTAL ATTACHMENTRecalls & reported problems across all models
Olympus Medical Systems Corp. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 97
- Deaths reported
- 0
- Injuries reported
- 71
- Recalls
- 0
We found 14 models of DISPOSABLE DISTAL ATTACHMENT by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Feb 28, 2019 and Jul 15, 2025 — classified as 71 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (32 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. 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
Reports received per month, all models
Most reported DISPOSABLE DISTAL ATTACHMENT problems
Device problems
- Adverse Event Without Identified Device or Use Problem47
- Detachment of Device or Device Component32
- Break10
- Device Reprocessing Problem6
- Crack3
- Material Split, Cut or Torn3
- Separation Problem3
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Hemorrhage/Blood Loss/Bleeding28
- Perforation26
- No Consequences Or Impact To Patient6
- Fever5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Foreign Body In Patient4
- Pancreatitis3
DISPOSABLE DISTAL ATTACHMENT models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DISPOSABLE DISTAL ATTACHMENT D-201-11804Gastroscope and accessories, flexible/rigid42 reports
- DISPOSABLE DISTAL ATTACHMENT D-201-10704Gastroscope and accessories, flexible/rigid15 reports
- DISPOSABLE DISTAL ATTACHMENT D-201-11804Gastroscope And Accessories, Flexible/Rigid11 reports
- DISPOSABLE DISTAL ATTACHMENT D-201-11802Gastroscope and accessories, flexible/rigid6 reports
- DISPOSABLE DISTAL ATTACHMENT D-201-14304Gastroscope and accessories, flexible/rigid5 reports
- DISPOSABLE DISTAL ATTACHMENT D-201-14304Gastroscope And Accessories, Flexible/Rigid5 reports
- DISPOSABLE DISTAL ATTACHMENT D-201-12704Gastroscope And Accessories, Flexible/Rigid3 reports
- DISPOSABLE DISTAL ATTACHMENT D-201-11304Gastroscope and accessories, flexible/rigid2 reports
- DISPOSABLE DISTAL ATTACHMENT D-201-12704Gastroscope and accessories, flexible/rigid2 reports
- DISPOSABLE DISTAL ATTACHMENT D-201-13404Gastroscope And Accessories, Flexible/Rigid2 reports
- DISPOSABLE DISTAL ATTACHMENT D-201-11802Gastroscope And Accessories, Flexible/Rigid1 report
- DISPOSABLE DISTAL ATTACHMENT D-201-11304Gastroscope And Accessories, Flexible/Rigid1 report
- DISPOSABLE DISTAL ATTACHMENT D-201-12704Gastroscope And Accessories, Flexible/Rigid1 report
- DISPOSABLE DISTAL ATTACHMENT D-201-14304Gastroscope And Accessories, Flexible/Rigid1 report
Recent DISPOSABLE DISTAL ATTACHMENT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT SIX (6) DISPOSABLE DISTAL ATTACHMENTS WERE BEING REPROCESSED AND USED. THE ISSUE WAS OBSERVED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 6 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507443 ↗MalfunctionJul 15, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT SIX (6) DISPOSABLE DISTAL ATTACHMENTS WERE BEING REPROCESSED AND USED. THE ISSUE WAS OBSERVED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 5 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507229 ↗MalfunctionJul 15, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT SIX (6) DISPOSABLE DISTAL ATTACHMENTS WERE BEING REPROCESSED AND USED. THE ISSUE WAS OBSERVED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 4 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507064 ↗MalfunctionJul 15, 2025Device Reprocessing Problem; Device Reprocessing Problem
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22506393 ↗MalfunctionJul 11, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT SIX (6) DISPOSABLE DISTAL ATTACHMENTS WERE BEING REPROCESSED AND USED. THE ISSUE WAS OBSERVED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 2 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478478 ↗MalfunctionJul 11, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT SIX (6) DISPOSABLE DISTAL ATTACHMENTS WERE BEING REPROCESSED AND USED. THE ISSUE WAS OBSERVED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 1 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478281 ↗MalfunctionJun 27, 2025Break; Break
IT WAS REPORTED THE DISPOSABLE DISTAL ATTACHMENT FIRST DISTAL CAP BROKE. A SECOND ONE WAS USED AND IT ALSO BROKE. THE ISSUE OCCURRED WHILE A PATIENT WAS UNDER SEDATION DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE AND WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345538 ↗MalfunctionJun 25, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22330772 ↗InjuryMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY, THE DISPOSABLE DISTAL ATTACHMENT FELL INSIDE THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE DISTAL ATTACHMENT USING ANOTHER SCOPE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22107035 ↗InjuryMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY, THE DISPOSABLE DISTAL ATTACHMENT FELL INSIDE THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE DISTAL ATTACHMENT USING ANOTHER SCOPE. 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 22107002 ↗InjuryApr 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: NO MEDICAL TAPE WAS USED TO SECURE THE PRODUCT AT THE DISTAL END OF THE SCOPE. LUBRICATING JELLY WAS USED AFTER THE CAP WAS IN PLACE SO SHOULD NOT HAVE CAUSED ANY SLIPPAGE. THE CAP WAS RETRIEVED WITH A GRASPER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21860188 ↗MalfunctionApr 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED; THE HOSPITAL STAFF WERE ASKED TO PROVIDE A DISTAL CAP FOR A DIAGNOSTIC GASTROSCOPY USING A GASTROINTESTINAL VIDEOSCOPE. THEY DID NOT HAVE THE APPROPRIATE SIZE CAP, AND THE DOCTOR SAID TO USE THE BIGGER DISPOSABLE DISTAL ATTACHMENT CAP ON THE SCOPE AND SECURE IT WITH STERI STRIPS. DURING THE PROCEDURE, THE CAP CAME OFF AND WAS NOT RETRIEVED. THE CAP IS EXPECTED TO PASS NATURALLY THROUGH THE GASTROINTESTINAL (GL) TRACT WITHOUT ADDITIONAL INTERVENTION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21780181 ↗InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERORAL ENDOSCOPIC MYOTOMY: SHORT VERSUS LONG ESOPHAGEAL MYOTOMY FOR ACHALASIA CARDIA: A RANDOMIZED CONTROLLED NON INFERIORITY TRIAL". LITERATURE SUMMARY BACKGROUND AND AIMS: THE APPROPRIATE LENGTH OF ESOPHAGEAL MYOTOMY IN PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ACHALASIA CARDIA REMAINS UNCLEAR. THIS STUDY AIMED TO COMPARE THE OUTCOME OF SHORT (= 3 CM) AND LONG (= 6 CM) ESOPHAGEAL MYOTOMY IN PATIENTS WITH TYPE I AND II ACHALASIA CARDIA. METHODS: THIS SINGLE-BLINDED, RANDOMIZED CONTROLLED NONINFERIORITY TRIAL WAS CONDUCTED AT A TERTIARY CENTER BETWEEN JULY 2021 AND DECEMBER 2021. PATIENTS WITH ACHALASIA TYPES I AND II WERE RANDOMIZED INTO SHORT (=3 CM) AND LONG (=6 CM) ESOPHAGEAL MYOTOMY GROUPS. THE PRIMARY OUTCOME OF THE STUDY WAS CLINICAL SUCCESS (ECKARDT SCORE =3) 1 YEAR AFTER THE PROCEDURE. THE SECONDARY OUTCOMES INCLUDED A COMPARISON OF TECHNICAL SUCCESS, OPERATING DURATION, OCCURRENCE OF INTRAOPERATIVE ADVERSE EVENTS, ALTERATIONS IN INTEGRATED RELAXATION PRESSURE (IRP), CHANGE IN BARIUM COLUMN HEIGHT AFTER 5 MINUTES (1 MO), AND GASTROESOPHAGEAL REFLUX DISEASE (3 MO) BETWEEN THE GROUPS. RESULTS: FIFTY-FOUR PATIENTS WERE RANDOMIZED
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding
MAUDE report 20790883 ↗InjuryOct 29, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SUBJECT DEVICE FELL INTO THE TRANSVERSE COLON AND WAS RETRIEVED USING GRASPING FORCEPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20556042 ↗InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "TRANSVERSE VERSUS LONGITUDINAL MUCOSAL INCISION DURING POEM FOR ESOPHAGEAL MOTILITY DISORDERS: A RANDOMIZED TRIAL". LONGITUDINAL INCISION IS THE COMMONLY USED INCISION FOR ENTRY INTO THE SUBMUCOSAL SPACE DURING PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ESOPHAGEAL MOTILITY DISORDERS. TRANSVERSE INCISION IS ANOTHER ALTERNATIVE FOR ENTRY AND RETROSPECTIVE DATA SUGGEST IT HAS LESS OPERATIVE TIME AND CHANCE OF GAS-RELATED EVENTS. THIS WAS A SINGLE-CENTER, RANDOMIZED TRIAL CONDUCTED AT A TERTIARY CARE HOSPITAL. PATIENTS UNDERGOING POEM FOR ESOPHAGEAL MOTILITY DISORDERS WERE RANDOMIZED INTO GROUP A (LONGITUDINAL INCISION) AND GROUP B (TRANSVERSE INCISION). THE PRIMARY OBJECTIVE WAS TO COMPARE THE TIME NEEDED FOR ENTRY INTO THE SUBMUCOSAL SPACE. THE SECONDARY OBJECTIVES WERE TO COMPARE THE TIME NEEDED TO CLOSE THE INCISION, NUMBER OF CLIPS REQUIRED TO CLOSE THE INCISION, AND DEVELOPMENT OF GAS-RELATED EVENTS. THE SAMPLE SIZE WAS CALCULATED AS FOR A NON-INFERIORITY DESIGN USING KELSEY METHOD. SIXTY PATIENTS WERE RANDOMIZED (30 IN EACH GROUP). ON COMPARING THE 2 TYPES OF INCISIONS, THERE WAS NO DIFFERENCE IN ENTRY TIME [3 (2, 5)
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding
MAUDE report 20500230 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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