Olympus WA03310ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04042761082303), received between Aug 13, 2018 and May 16, 2024 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unclear Information” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2024Melted; Melted

  IT WAS REPORTED THAT WHEN THE LIGHT GUIDE CABLE WAS PLACED ON TOP OF A DRAPE DURING TREATMENT, THE DRAPE MELTED. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336282 ↗
• MalfunctionApr 7, 2023Use of Device Problem; Use of Device Problem

  AS REPORTED, (COMBINATION USE ) OF THE DEVICE WAIR130A (TELESCOPE RIR) AND WA03310A (LIGHT GUIDE CABLE) WERE USED IN A THERAPEUTIC LAPAROSCOPIC ILEOCECAL RESECTION. THE GOWN WORN BY THE DOCTOR DURING THE WOUND CLOSURE PROCESS WAS BURNT. IT WAS REPORTED THAT IN THE SECOND HALF OF THE PROCEDURE, WHILE THE INTRAPERITONEAL OPERATION WAS OVER AND THE DOCTOR WAS CLOSING THE WOUND, WAIR130A AND WA03310A WERE PUT IN THE POCKET OF THE DRAPE WITHOUT TURNING OFF THE LIGHT SOURCE., WHILE THE DOCTOR WAS CLOSING THE WOUND, THE GOWN THE DOCTOR WAS WEARING WAS SCORCHED . THE HEAT FROM THE TIP OF THE OPTICAL VIEWING TUBE SCORCHED THE GOWN. THERE WAS NO INJURY OR HARM DUE TO SCORCHING. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED AS THE RESULT OF THE EVENT. THE INTENDED PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. PER THE REPORT IN ADDITION, THERE WAS NO PARTICULAR ISSUE WITH THE LIGHTGUIDE/LIGHTSOURCE ( CLL-S700). THIS EVENT INCLUDES TWO (2) REPORTS CAPTURING THE 2 DEVICES ADDRESSED ON THIS EVENT. REPORT WITH PATIENT IDENTIFIER (B)(6)- TELESCOPE IR MODEL WAIR130A SN: (B)(4). REPORT WITH PATIENT IDENTIFIER (B)(6)- LIGHT-GUIDE CABLE MODEL WA03310A LOT 229W0002. THIS REPORT BEING SUBMITTED IS FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704436 ↗
• InjuryAug 12, 2020Unclear Information; Unclear Information

  OLYMPUS WAS INFORMED THAT AFTER A CHOLECYSTOTOMY PROCEDURE, A RE-HOSPITALIZATION AND SURGICAL RESUMPTION WAS REQUIRED. IT WAS REPORTED THAT THE PRACTITIONER SUSPECTS A MATERIAL DEFECT. DESPITE SEVERAL EFFORTS TO DATE, NO FURTHER INFORMATION WAS PROVIDED SO FAR.

  Patient problems: Bowel Burn; Injury; No Information

  MAUDE report 10395588 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PEDIATRIC SURGERY, THE PATIENT SUSTAINED A SECOND DEGREE BURN WHEN THE LIGHT-GUIDE CABLE AND THE CONNECTING PART OF THE RIGID ENDOSCOPE CAME INTO CONTACT WITH THE PATIENT¿S SKIN. THE AFFECTED AREA WAS 2 CM X 5 MM IN SIZE. IT WAS REPORTED THAT THE BURN DID NOT REQUIRE ANY MEDICAL OR SURGICAL TREATMENT. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME OF EQUIPMENT.

  Patient problems: Burn, Thermal

  MAUDE report 10263313 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE THE PATIENT SUSTAINED A BURN INJURY WHEN THE ACTIVATED WA03310A LIGHT-GUIDE CABLE WAS PLACED ON THE PATIENT¿S ABDOMEN WITH NO TELESCOPE CONNECTED. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT A MALFUNCTION OF THE OLYMPUS MEDICAL DEVICES.

  Patient problems: Burn(s)

  MAUDE report 10064336 ↗
• MalfunctionJun 17, 2019Unclear Information; Unclear Information

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE PATIENT SUSTAINED A BURN INJURY OF AN UNKNOWN DEGREE IN THE RIGHT ABDOMEN AND INGUINAL REGION RESULTING FROM THE SHEET COVERING THE PATIENT WHICH CAUGHT FIRE. HOWEVER, IT IS UNCLEAR WHETHER THE INJURY WAS CAUSED BY A MALFUNCTION OF ANY OF THE OLYMPUS DEVICES. NO FURTHER INFORMATION WAS PROVIDED BUT THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT.

  Patient problems: Burn(s)

  MAUDE report 8703489 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), THE PATIENT SUSTAINED A BURN ON THE INNER THIGH WHICH REQUIRED FURTHER TREATMENT. NO FURTHER INFORMATION WAS PROVIDED AND THERE WAS NO REPORT ABOUT A MALFUNCTION OF ANY OF THE MEDICAL DEVICES. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT.

  Patient problems: Burn, Thermal

  MAUDE report 8373476 ↗
• InjuryAug 13, 2018Fire; Electrical Shorting; Fire; Electrical Shorting

  OLYMPUS WAS INFORMED THAT PRIOR TO A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, THE LINER CLOTH CAUGHT FIRE AFTER THE LIGHT-GUIDE CABLE WAS CONNECTED TO THE LIGHT SOURCE. FOR FIVE TO TEN MINUTES THE LIGHT SOURCE WAS IN STANDBY MODE AND THE LIGHT-GUIDE CABLE WAS NOT CONNECTED TO THE RIGID SCOPE. THE FIRE OF THE LINER CLOTH CAUSED A THIRD-DEGREE BURN CLOSE TO THE PATIENT¿S WAIST. AN INCISION WAS MADE TO REMOVE THE DEAD SKIN AND THE WOUND WAS SUTURED AFTERWARDS TO CLOSE IT. NO FURTHER INFORMATION WAS PROVIDED, BUT THE INTENDED PROCEDURE WAS THEN SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 7776104 ↗