Olympus WA51138ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04042761024341), received between Aug 2, 2018 and Sep 25, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K923982); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902693 ↗
• MalfunctionMay 8, 2026Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123759 ↗
• MalfunctionMar 23, 2026Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUCTION/IRRIGATION TUBE EXHIBITED DAMAGED INSULATION, THERMAL DECOMPOSITION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670314 ↗
• MalfunctionNov 10, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE SUCTION/IRRIGATION TUBE HAD A BLACK DOT THAT CAME OUT FROM INSIDE THE LUMEN DURING FLUSHING. THE ISSUE WAS FOUND DURING REPROCESSING, AND THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110939 ↗
• MalfunctionSep 27, 2023Melted; Melted

  THE CUSTOMER REPORTED THAT AT THE END OF THE PROCEDURE, THE STAFF CONFIRMED A MELTED CRACK AT THE TIP OF HIS OLYMPUS UNIPOLAR SUCTION TUBE. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES OR HARM TO THE PATIENT. THE ITEM HAD BEEN COLLECTED. THE CUSTOMER ALSO NOTED THAT AS ONLY THE SUBJECT DEVICE WAS ENERGIZED, THE COMBINED PRODUCT WAS NOT ISSUED. THE CUSTOMER WENT ON TO CONFIRM THAT THE HIGH FREQUENCY WAS MADE BY A 3RD PARTY COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17824381 ↗
• InjuryAug 23, 2023Sparking; Sparking

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT SPARKS OCCURRED WHEN THE TIP OF THE SUCTION/IRRIGATION TUBE, 5 X 360 MM, BUTTON, UNIPOLAR, FOR HIQ+ HANDLE MADE CONTACT WITH THE TISSUE WHILE USED TOGETHER WITH A THIRD-PARTY ELECTROSURGICAL GENERATOR DURING A LAPAROSCOPIC COLECTOMY RESULTING TO A BOWEL BURN AND MESENTERIC ARTERY DAMAGE REQUIRING CONVERSION FROM LAPAROSCOPIC TO OPEN SURGERY, WHICH WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PATIENT WAS ADMITTED FOR ROUTINE POST OPERATIVE CARE AFTER OPEN SURGERY. NO FURTHER PROBLEMS WERE REPORTED. THE GENERATOR WAS SET AT SOFT CORE 80 WATTS. THE DEVICE'S OUTPUT WAS INSPECTED PRIOR TO USE WITHOUT ANY ISSUES NOTED.

  Patient problems: Bowel Burn

  MAUDE report 17602595 ↗
• InjuryNov 10, 2022Sparking; Insufficient Device Problem Information; Sparking; Insufficient Device Problem Information

  OLYMPUS WAS INFORMED THAT AFTER COMPLETION OF A THERAPEUTIC LAPAROSCOPIC SPLEEN CYST REMOVAL PROCEDURE IT WAS NOTICED THAT THE PATIENT HAD SUSTAINED A 4TH DEGREE SKIN BURN APPROX. 1 CM FROM THE TROCAR WHERE THE MONOPOLAR SUCTION/IRRIGATION TUBE HAD BEEN INSERTED. THE TISSUE AROUND THE TROCAR HAD TO BE SURGICALLY REMOVED DUE TO THE BURN INJURY BUT NO FURTHER TREATMENT WAS REQUIRED. THE INTENDED PROCEDURE HAD BEEN PERFORMED USING A KLS MARTIN MAXIUM® ELECTROSURGICAL GENERATOR WITH THE SETTINGS CUT 33 AND COAG SPRAY 58. THE SUCTION/IRRIGATION TUBE HAD BEEN INSPECTED BEFORE USE AND NO DEFECTS WERE FOUND BUT AFTER THE SURGERY ITS INSULATION WAS FOUND TO BE DAMAGED.

  Patient problems: Burn(s)

  MAUDE report 15769436 ↗
• MalfunctionOct 24, 2022Material Fragmentation; Material Fragmentation

  OLYMPUS WAS INFORMED THAT DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, A BLACK PLASTIC-LIKE FOREIGN BODY ABOUT 1 MM IN SIZE WAS FOUND IN THE PATIENT¿S ABDOMINAL CAVITY WHILE THE ORGANS WERE BEING WASHED WITH A WATER SUPPLY SUCTION TUBE. IT IS SUSPECTED THAT THE BLACK MATERIAL COMES FROM THE BLACK HANDLE OF THE SUCTION/IRRIGATION TUBE (WA51138A) SINCE IT WAS FOUND TO BE SLIGHTLY SCRAPED. HOWEVER, THE FRAGMENT WAS RETRIEVED, AND THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT OF AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657421 ↗
• MalfunctionSep 29, 2020Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, A FRAGMENT OF THE ELECTRICAL INSULATION OF THE SUCTION/IRRIGATION TUBE BROKE OFF AND FELL INTO THE PATIENT¿S BODY CAVITY. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10599180 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT AFTER A THERAPEUTIC TOTAL LAPAROSCOPIC GASTRECTOMY PROCEDURE THE PATIENT DEVELOPED PERITONITIS. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WERE NO REPORTS OF ANY DEVICE MALFUNCTIONS.

  Patient problems: Peritonitis

  MAUDE report 10037763 ↗
• MalfunctionAug 2, 2018Melted; Material Deformation; Melted; Material Deformation

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC LAPAROSCOPIC PROCEDURE, THE INSULATION AT THE DISTAL END OF THE SUCTION/IRRIGATION TUBE MELTED WHILE IT WAS USED AS A MONOPOLAR BUTTON ELECTRODE IN SPRAY COAGULATION MODE. IT IS UNKNOWN WHEN EXACTLY THIS DAMAGE OCCURRED AND WHETHER A FRAGMENT OF THE INSULATION FELL INSIDE THE PATIENT'S BODY CAVITY. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7741762 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923982. One submission often covers many models, so check the product and lot details in each record.

• Z-1163-2010 · Feb 8, 2010 · Terminated
  Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal acce