Olympus WA58365SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761030779), received between Jan 26, 2021 and Oct 14, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THORACOSCOPY, THE FIRST THORACOSCOPY PAN THE PHYSICIAN OPENED WAS MISSING THE 10 MM METAL OBTURATOR FOR THE METAL TROCAR. A SECOND PAN WAS OPENED. UPON USING THE 10 MM TROCAR, WHEN THE PHYSICIAN WENT TO MOVE THE OBTURATOR, ONLY THE PLASTIC TOP OF THE OBTURATOR CAME OUT. THE METAL END OF THE OBTURATOR FELL THROUGH THE TROCAR INTO THE PATIENT¿S CHEST. IT TOOK THE PHYSICIAN 45-60 MINUTES TO FIND AND REMOVE THE FOREIGN METAL OBJECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446216 ↗
• InjuryOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THORACOSCOPY, THE FIRST THORACOSCOPY PAN THE PHYSICIAN OPENED WAS MISSING THE 10 MM METAL OBTURATOR FOR THE METAL TROCAR. A SECOND PAN WAS OPENED. UPON USING THE 10 MM TROCAR, WHEN THE PHYSICIAN WENT TO MOVE THE OBTURATOR, ONLY THE PLASTIC TOP OF THE OBTURATOR CAME OUT. THE METAL END OF THE OBTURATOR FELL THROUGH THE TROCAR INTO THE PATIENT¿S CHEST. IT TOOK THE PHYSICIAN 45-60 MINUTES TO FIND AND REMOVE THE FOREIGN METAL OBJECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20445849 ↗
• InjuryMay 26, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC THORACIC SURGERY, THIS LAPAROSCOPIC TROCAR BLADE CAME APART AND FELL INTO THE PATIENT'S CHEST CAVITY. THE OBTURATOR WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17012351 ↗
• InjuryMay 26, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC THORACIC SURGERY, THIS LAPAROSCOPIC TROCAR BLADE CAME APART AND FELL INTO THE PATIENT'S CHEST CAVITY. THE OBTURATOR WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17012071 ↗
• InjuryMay 8, 2023Material Fragmentation; Material Fragmentation

  OLYMPUS RECEIVED A MEDWATCH REPORT (2301650000-2023-8005) THROUGH THE MAIL WHICH STATING "WHILE SCRUBBED INTO DOCTOR'S VIDEO-ASSISTED THORACIC SURGERY (VATS) CASE AND I HANDED HIM AN 11MM TROCAR OBTURATOR. AFTER HE INSERTED IT, HE ONLY HANDED ME BACK A PIECE OF PLASTIC, INSTEAD OF THE OBTURATOR. THE PLASTIC WAS PART OF THE OBTURATOR. THE METAL PORTION OF THE OBTURATOR WAS NOT RETURNED TO ME, I INFORMED HIM THAT I DID NOT GET IT. ON FURTHER EXAMINATION, WE FOUND THAT THE OBTURATOR CAME APART. THEY FEEL INTO THE PATIENT'S CHEST CAVITY. THE OBTURATOR WAS RETRIEVED FROM THE PATIENT. THE ENTIRE SILVER PORTION DROPPED INTO THE BODY CAVITY; ONLY THE BLACK HANDLE WAS GIVEN TO THE SCRUB TECH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885765 ↗
• InjuryMay 5, 2023Material Fragmentation; Material Fragmentation

  OLYMPUS RECEIVED A MEDWATCH REPORT (B)(4) THROUGH THE MAIL WHICH STATING "WHILE SCRUBBED INTO DOCTOR'S VIDEO-ASSISTED THORACIC SURGERY (VATS) CASE AND I HANDED HIM AN 11MM TROCAR OBTURATOR. AFTER HE INSERTED IT, HE ONLY HANDED ME BACK A PIECE OF PLASTIC, INSTEAD OF THE OBTURATOR. THE PLASTIC WAS PART OF THE OBTURATOR. THE METAL PORTION OF THE OBTURATOR WAS NOT RETURNED TO ME, I INFORMED HIM THAT I DID NOT GET IT. ON FURTHER EXAMINATION, WE FOUND THAT THE OBTURATOR CAME APART. THEY FEEL INTO THE PATIENT'S CHEST CAVITY. THE OBTURATOR WAS RETRIEVED FROM THE PATIENT. THE ENTIRE SILVER PORTION DROPPED INTO THE BODY CAVITY; ONLY THE BLACK HANDLE WAS GIVEN TO THE SCRUB TECH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16879835 ↗
• InjuryJan 26, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THORACOSCOPY PROCEDURE, WHEN INSERTING THE TROCAR, THE MANDREL OF THE TROCAR SPIKE BROKE AND THE ROD SLID ALONG THE TROCAR SLEEVE TO PROTRUDE INTO THE THORAX. THE SURGEON MANAGED TO RECOVER THE METAL ROD BUT THE OPERATION/ANESTHESIA WAS PROLONGED AS A RESULT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11228549 ↗

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