Olympus WA90002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04042761082969), received between Aug 24, 2022 and Sep 13, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Output above Specifications” (3 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY AN OLYMPUS TERRITORY MANAGER, THE PATIENT'S TURBINATE WAS BEING OVERTREATED DURING A SUBMUCOSAL RESECTION (SMR) PROCEDURE USING THE ELECTROSURGICAL GENERATOR. IT WAS REPORTED THE OUTPUT FROM THE HANDPIECE WAS HIGH AND THE TISSUE EXPERIENCED NECROSIS. THE CUSTOMER WAS ADVISED TO TURN DOWN THE OUTPUT OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, AND THERE WERE NO REPORTS OF A DEVICE MALFUNCTION. IT WAS REPORTED THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE, AND NO ANOMALIES WERE FOUND. FOLLOW-UP WITH THE PHYSICIAN INDICATED THE NECROSIS ISSUE WAS NOTED AT THE FIRST FOLLOW-UP APPOINTMENT AFTER THE PROCEDURE. THE PHYSICIAN REPORTED THREE (3) PATIENTS EXPERIENCED NECROSIS OF THE HEAD AND MID-BODY OF THE INFERIOR TURBINATE. THERE WERE ALLEGEDLY NO CLINICAL SYMPTOMS, BUT THE PHYSICIAN HAD A CONCERN FOR LONG TERM EMPTY NOSE SYNDROME. THE TISSUE NECROSIS WAS TREATED WITH DEBRIDEMENT AND OBSERVATION. THE PHYSICIAN REPORTED 2 DEVICES WERE INVOLVED WITH THE EVENT: WA90002A, SERIAL (B)(4), AND WB990310, LOT 1000084723. THE 3 PATIENTS INVOLVED AND THE CORRESPONDING DEVICES ARE AS FOLLOWS: CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS 75 YEAR OLD ASIAN MALE, WA90002

  Patient problems: Necrosis

  MAUDE report 15414577 ↗
• InjurySep 13, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY AN OLYMPUS TERRITORY MANAGER, THE PATIENT'S TURBINATE WAS BEING OVERTREATED DURING A SUBMUCOSAL RESECTION (SMR) PROCEDURE USING THE ELECTROSURGICAL GENERATOR. IT WAS REPORTED THE OUTPUT FROM THE HANDPIECE WAS HIGH AND THE TISSUE EXPERIENCED NECROSIS. THE CUSTOMER WAS ADVISED TO TURN DOWN THE OUTPUT OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, AND THERE WERE NO REPORTS OF A DEVICE MALFUNCTION. IT WAS REPORTED THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE, AND NO ANOMALIES WERE FOUND. FOLLOW-UP WITH THE PHYSICIAN INDICATED THE NECROSIS ISSUE WAS NOTED AT THE FIRST FOLLOW-UP APPOINTMENT AFTER THE PROCEDURE. THE PHYSICIAN REPORTED THREE (3) PATIENTS EXPERIENCED NECROSIS OF THE HEAD AND MID-BODY OF THE INFERIOR TURBINATE. THERE WERE ALLEGEDLY NO CLINICAL SYMPTOMS, BUT THE PHYSICIAN HAD A CONCERN FOR LONG TERM EMPTY NOSE SYNDROME. THE TISSUE NECROSIS WAS TREATED WITH DEBRIDEMENT AND OBSERVATION. THE PHYSICIAN REPORTED 2 DEVICES WERE INVOLVED WITH THE EVENT: WA90002A, SERIAL (B)(4), AND WB990310, LOT 1000084723. THE 3 PATIENTS INVOLVED AND THE CORRESPONDING DEVICES ARE AS FOLLOWS: CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS 75 YEAR OLD ASIAN MALE, WA90002

  Patient problems: Necrosis

  MAUDE report 15414562 ↗
• InjurySep 13, 2022Output above Specifications

  IT WAS REPORTED BY AN OLYMPUS TERRITORY MANAGER, THE PATIENT'S TURBINATE WAS BEING OVERTREATED DURING A SUBMUCOSAL RESECTION (SMR) PROCEDURE USING THE ELECTROSURGICAL GENERATOR. IT WAS REPORTED THE OUTPUT FROM THE HANDPIECE WAS HIGH AND THE TISSUE EXPERIENCED NECROSIS. THE CUSTOMER WAS ADVISED TO TURN DOWN THE OUTPUT OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, AND THERE WERE NO REPORTS OF A DEVICE MALFUNCTION. IT WAS REPORTED THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE, AND NO ANOMALIES WERE FOUND. FOLLOW-UP WITH THE PHYSICIAN INDICATED THE NECROSIS ISSUE WAS NOTED AT THE FIRST FOLLOW-UP APPOINTMENT AFTER THE PROCEDURE. THE PHYSICIAN REPORTED THREE (3) PATIENTS EXPERIENCED NECROSIS OF THE HEAD AND MID-BODY OF THE INFERIOR TURBINATE. THERE WERE ALLEGEDLY NO CLINICAL SYMPTOMS, BUT THE PHYSICIAN HAD A CONCERN FOR LONG TERM EMPTY NOSE SYNDROME. THE TISSUE NECROSIS WAS TREATED WITH DEBRIDEMENT AND OBSERVATION. THE PHYSICIAN REPORTED 2 DEVICES WERE INVOLVED WITH THE EVENT: WA90002A, SERIAL (B)(4), AND WB990310, LOT 1000084723. THE 3 PATIENTS INVOLVED AND THE CORRESPONDING DEVICES ARE AS FOLLOWS: CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS 75 YEAR OLD ASIAN MALE, WA90002

  Patient problems: Necrosis

  MAUDE report 15414502 ↗
• InjurySep 13, 2022Output above Specifications

  IT WAS REPORTED BY AN OLYMPUS TERRITORY MANAGER, THE PATIENT'S TURBINATE WAS BEING OVERTREATED DURING A SUBMUCOSAL RESECTION (SMR) PROCEDURE USING THE ELECTROSURGICAL GENERATOR. IT WAS REPORTED THE OUTPUT FROM THE HANDPIECE WAS HIGH AND THE TISSUE EXPERIENCED NECROSIS. THE CUSTOMER WAS ADVISED TO TURN DOWN THE OUTPUT OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, AND THERE WERE NO REPORTS OF A DEVICE MALFUNCTION. IT WAS REPORTED THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE, AND NO ANOMALIES WERE FOUND. FOLLOW-UP WITH THE PHYSICIAN INDICATED THE NECROSIS ISSUE WAS NOTED AT THE FIRST FOLLOW-UP APPOINTMENT AFTER THE PROCEDURE. THE PHYSICIAN REPORTED THREE (3) PATIENTS EXPERIENCED NECROSIS OF THE HEAD AND MID-BODY OF THE INFERIOR TURBINATE. THERE WERE ALLEGEDLY NO CLINICAL SYMPTOMS, BUT THE PHYSICIAN HAD A CONCERN FOR LONG TERM EMPTY NOSE SYNDROME. THE TISSUE NECROSIS WAS TREATED WITH DEBRIDEMENT AND OBSERVATION. THE PHYSICIAN REPORTED 2 DEVICES WERE INVOLVED WITH THE EVENT: (B)(4), SERIAL (B)(4), LOT 1000084723. THE 3 PATIENTS INVOLVED AND THE CORRESPONDING DEVICES ARE AS FOLLOWS: CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS 75 YEAR OLD ASIAN MALE, (B)(4), CASE WITH PATIE

  Patient problems: Necrosis

  MAUDE report 15414491 ↗
• InjuryAug 24, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY AN OLYMPUS TERRITORY MANAGER, THE PATIENT'S TURBINATE WAS BEING OVERTREATED DURING A SUBMUCOSAL RESECTION PROCEDURE USING THE ELECTROSURGICAL GENERATOR. IT WAS REPORTED THE OUTPUT FROM THE HANDPIECE WAS HIGH AND TISSUE WAS EXPERIENCING NECROSIS. THE CUSTOMER WAS ADVISED TO TURN DOWN THE OUTPUT OF THE DEVICE. THE OLYMPUS REPRESENTATIVE PLANS TO PROVIDE THE CUSTOMER WITH AN ADDITIONAL IN-SERVICE ON OPERATING THE DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, AND THERE WERE NO REPORTS OF A DEVICE MALFUNCTION. IT WAS REPORTED THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE, AND NO ANOMALIES WERE FOUND. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT.

  Patient problems: Necrosis

  MAUDE report 15288709 ↗
• InjuryAug 24, 2022Output above Specifications

  IT WAS REPORTED BY AN OLYMPUS TERRITORY MANAGER, THE PATIENT'S TURBINATE WAS BEING OVERTREATED DURING A SUBMUCOSAL RESECTION PROCEDURE USING THE ELECTROSURGICAL GENERATOR. IT WAS REPORTED THE OUTPUT FROM THE HANDPIECE WAS HIGH AND TISSUE WAS EXPERIENCING NECROSIS. THE CUSTOMER WAS ADVISED TO TURN DOWN THE OUTPUT OF THE DEVICE. THE OLYMPUS REPRESENTATIVE PLANS TO PROVIDE THE CUSTOMER WITH AN ADDITIONAL IN-SERVICE ON OPERATING THE DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, AND THERE WERE NO REPORTS OF A DEVICE MALFUNCTION. IT WAS REPORTED THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE, AND NO ANOMALIES WERE FOUND. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT.

  Patient problems: Necrosis

  MAUDE report 15288646 ↗