DISPOSABLE NEEDLE MAJ-656Recalls & reported problems
Olympus Medical Systems Corp. · DISPOSABLE NEEDLE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170062469), received between Jul 13, 2021 and Jul 13, 2021 — classified as 2 injuries.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED DURING A BLADDER BOTOX PROCEDURE USING A DISPOSABLE NEEDLE, THE NURSE EXPERIENCED A NEEDLE STICK WHEN WITHDRAWING THE NEEDLE FROM SHEATH. BOTH THE PATIENT AND NURSE REQUIRED BLOOD DRAWS TO RULE OUT CROSS INFECTION BETWEEN THEM. THE LAB RESULTS SHOWED THERE WAS NO DISEASE TRANSMISSION BETWEEN THE TWO. IT IS REPORTED THERE WAS NOT MALFUNCTION OF THE NEEDLE. THE NEEDLE WAS DISCARDED BY THE FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12160773 ↗InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem
IT IS REPORTED DURING A BLADDER BOTOX PROCEDURE USING A DISPOSABLE NEEDLE, THE NURSE EXPERIENCED A NEEDLE STICK WHEN WITHDRAWING THE NEEDLE FROM SHEATH. BOTH THE PATIENT AND NURSE REQUIRED BLOOD DRAWS TO RULE OUT CROSS INFECTION BETWEEN THEM. THE LAB RESULTS SHOWED THERE WAS NO DISEASE TRANSMISSION BETWEEN THE TWO. IT IS REPORTED THERE WAS NOT MALFUNCTION OF THE NEEDLE. THE NEEDLE WAS DISCARDED BY THE FACILITY.
Patient problems: Needle Stick/Puncture
MAUDE report 12160689 ↗
Other FORCEPS, BIOPSY, ELECTRIC devices
- HALOGEN LIGHT SOURCE OLYMPUS CLK-4Olympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC65 reports
- Single Use Electrosurgical Hemostatic Forceps FD-410LROlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC46 reports
- Radial Jaw 4 M00515030Boston Scientific Corporation · FORCEPS, BIOPSY, ELECTRIC29 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5AOlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC24 reports
- Single Use Electrosurgical Hemostatic Forceps FD-412LROlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC17 reports
- Single Use Electrosurgical Hemostatic Forceps FD-411UROlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC15 reports
- SUCTION VALVE MAJ-207Olympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC13 reports
- Captura G31583Cook Incorporated · FORCEPS, BIOPSY, ELECTRIC13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page