Olympus WA64120CRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Jaws "HiQ+", bipolar, 5 x 330 mm, Grasping forceps, fenestrated · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus Jaws HiQ+ bipolar grasping forceps has 40 adverse event reports, all describing malfunctions such as broken, split, torn, or loose/detached parts. The reports mention no deaths or injuries. There are no recalls that 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
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 04042761062411), received between Mar 3, 2021 and Sep 3, 2026 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Break” (14 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break14
- Material Split, Cut or Torn8
- Detachment of Device or Device Component5
- Material Integrity Problem3
- Defective Component2
- Material Deformation2
- Naturally Worn2
- Peeled/Delaminated2
Patient problems
- No Clinical Signs, Symptoms or Conditions40
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599479 ↗MalfunctionAug 18, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310766 ↗MalfunctionAug 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50308940 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THE RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS EXHIBITED A BROKEN DISTAL END. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24706046 ↗MalfunctionDec 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP WHERE IT ATTACHES TO THE HANDLE OF THE JAWS WAS LOOSE. NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23896377 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP WHERE IT ATTACHES TO THE HANDLE OF THE JAWS WAS LOOSE. NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863762 ↗MalfunctionDec 8, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED INSULATION OF THE BIPOLAR INSERT IS DAMAGED. THERE WERE NO REPORT S OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23745366 ↗MalfunctionDec 8, 2025Naturally Worn; Naturally Worn
NO NEW INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23735992 ↗MalfunctionOct 20, 2025Defective Component; Defective Component
IT WAS REPORTED THAT THE SUBJECT DEVICE¿S BIPOLAR FORCEPS JAWS COULD NOT CLOSE. THE ISSUE WAS OBSERVED DURING OPEN BOX INSPECTION OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23336432 ↗MalfunctionOct 17, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE HAD A BROKEN DISTAL END. THE ISSUE WAS OBSERVED DURING INSPECTION BEFORE USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23324236 ↗MalfunctionAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE JAWS EXHIBITED A DETACHED PROXIMAL PART. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22881743 ↗MalfunctionJul 31, 2025Break; Break
IT WAS REPORTED THE GRASPING FORCEPS TEFLON LAYER WAS OBSERVED DAMAGED. THE ISSUE WAS DISCOVERED DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22673091 ↗MalfunctionJun 17, 2025Break; Break
IT WAS REPORTED THAT THE¿SUBJECT DEVICE¿HAD¿FORCEPS WITH BROKEN ROD. ¿THE ISSUE WAS FOUND DURING A LAPAROSCOPIA THERAPEUTIC PROCEDURE THAT WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22235791 ↗MalfunctionMay 1, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942159 ↗MalfunctionApr 28, 2025Break; Break
IT WAS REPORTED THE INSULATION OF THE GRASPING FORCEPS' INSERT WAS DAMAGED. THE REPORTED ISSUE WAS DISCOVERED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE.THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21922807 ↗MalfunctionApr 17, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE GRASPING JAWS INSULATION WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21858895 ↗MalfunctionJan 10, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21124229 ↗MalfunctionOct 4, 2024Material Deformation; Material Deformation
IT WAS REPORTED THE OPENING ANGLE OF THE TIP GRIP OF THE RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS WAS INSUFFICIENT. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20368673 ↗MalfunctionJul 16, 2024Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close
IT WAS REPORTED THAT DURING REPROCESSING, THE DETACHMENT OF THE TEFLON PIN ON THE JAW RESULTED IN THE INABILITY TO OPEN CLOSE THE JAW ON ONE SIDE. NO PATIENT INJURY REPORTED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19757694 ↗MalfunctionJul 15, 2024Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GRASPING FORCEPS EXHIBITED DETACHMENT OF THE TEFLON PIN ON THE JAW RESULTING INTO THE INABILITY TO OPEN AND CLOSE THE JAW ON ONE SIDE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19740556 ↗MalfunctionJun 7, 2024Break; Break
IT WAS REPORTED, THE GRASPING FORCEPS HAD DAMAGE TO THE PLASTIC INSULATION OF THE END OF THE JAWS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19484228 ↗MalfunctionMay 6, 2024Break; Break
IT WAS REPORTED THE FORCEPS END RIPPED OFF. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19255121 ↗MalfunctionOct 11, 2023Naturally Worn; Naturally Worn
THE CUSTOMER REPORTED TO OLYMPUS, THE JAWS "HIQ+" WHITE PART OF THE JAW ON THE PRODUCT HAD WHITE INSULATION THAT WAS WORN ON SEVERAL PRODUCTS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17916341 ↗MalfunctionSep 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
THE CUSTOMER REPORTED THAT THE INSULATION AT THE DISTAL END OF HIS OLYMPUS JAWS GRASPING FORCEPS WAS FOUND TORN ON SEVERAL UNITS. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THESE EVENTS. THIS REPORT IS 6 OF 8. PLEASE SEE REPORTS WITH THE FOLLOWING PATIENT IDENTIFIERS FOR RELATED EVENTS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17804532 ↗MalfunctionSep 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
THE CUSTOMER REPORTED THAT THE INSULATION AT THE DISTAL END OF HIS OLYMPUS JAWS GRASPING FORCEPS WAS FOUND TORN ON SEVERAL UNITS. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THESE EVENTS. THIS REPORT IS 7 OF 8. PLEASE SEE REPORTS WITH THE FOLLOWING PATIENT IDENTIFIERS FOR RELATED EVENTS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17803324 ↗
Other Electrosurgical, Cutting & Coagulation & Accessories devices
- Vasoview Hemopro 2 VH-4000Maquet Cardiovascular LLC · Electrosurgical, Cutting & Coagulation & Accessories6 recalls1 death3,232 reports
- LigaSure LF1937Covidien LP · Electrosurgical, cutting & coagulation & accessories3 deaths2,090 reports
- Olympus WB91051WOLYMPUS Winter & Ibe GmbH · Electrosurgical, Cutting & Coagulation & Accessories1 death1,951 reports
- Valleylab FT10 VLFT10GENCovidien LP · Electrosurgical, cutting & coagulation & accessories1 recall5 deaths1,062 reports
- LigaSure LF1837Covidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall967 reports
- LigaSure LF2019Covidien LP · Electrosurgical, cutting & coagulation & accessories948 reports
- VAPR 225028Depuy Mitek, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES895 reports
- LigaSure LF1923Covidien LP · Electrosurgical, cutting & coagulation & accessories855 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