olympus A42021ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761023665), received between Jul 12, 2023 and Sep 21, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Detachment of Device or Device Component

  The customer returned the reusable endoscope sheath for a separate issue. No patient involvement. During inspection of the returned device, it was found the distal end was chipped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841930 ↗
• MalfunctionAug 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123113 ↗
• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED THE OUTER SHEATH EXHIBITED A DAMAGED CERAMIC TIP. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23800236 ↗
• MalfunctionAug 21, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT WHILE USING THE SHEATH WITH THE HIGH FREQUENCY UNIT, THE HIGH FREQUENCY UNIT EXHIBITED AN ERROR (INSTRUMENT CANNOT BE RECOGNIZED. UPON CHECKING THE PLASMA ELECTRIC CUTTING INTERFACE, IT WAS FOUND THAT THE INTERFACE WAS LOOSE AND SUSPECTED THAT POOR INTERFACE CONTACT HAD CAUSED THE MALFUNCTION. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC SURGERY. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20017247 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT AN ELECTRICAL FAILURE OCCURRED AND NO IMAGE DURING THE HYSTEROSCOPIC MYOMECTOMY AND THE SAME PROBLEM OCCURRED AFTER REPLACING ALL THE COMBINED DEVICES CAUSING A 30-MINUTE DELAY IN SURGERY AND 30 MINUTES EXTENDED ANESTHESIA TIME. THERE WERE NO ERROR MESSAGES. THE PROCEDURE WAS COMPLETED USING OTHER UROLOGICAL PRODUCTS. THE EVENT DID NOT AFFECT THE DIAGNOSTIC OR TREATMENT OUTCOME. THERE WERE NO REPORTS OF PATIENT HARM. THIS EVENT REQUIRES 12 REPORTS. RELATED PATIENT IDENTIFIERS FOR THE FIRST COMBINATION OF DEVICES USED ARE AS FOLLOWS: (B)(6) (WA00014A / HF-CABLE, BIPOLAR), (B)(6) (WA00014A / HF-CABLE, BIPOLAR) , (B)(6) (A42011A / RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS), (B)(6) (A42021A / OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE), (B)(6) (WA22366A /WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE), (B)(6) (WB50402W / FOOT SWITCH, DOUBLE, FOR, ESG-400). RELATED PATIENT IDENTIFIERS FOR THE SECOND COMBINATION OF DEVICES USED: (B)(6) (WB50402W / FOOT SWITCH, DOUBLE, FOR, ESG-400), (B)(6) (WA22366A / WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE), (B)(6) (A42011A / RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372159 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT AN ELECTRICAL FAILURE OCCURRED AND NO IMAGE DURING THE HYSTEROSCOPIC MYOMECTOMY AND THE SAME PROBLEM OCCURRED AFTER REPLACING ALL THE COMBINED DEVICES CAUSING A 30-MINUTE DELAY IN SURGERY AND 30 MINUTES EXTENDED ANESTHESIA TIME. THERE WERE NO ERROR MESSAGES. THE PROCEDURE WAS COMPLETED USING OTHER UROLOGICAL PRODUCTS. THE EVENT DID NOT AFFECT THE DIAGNOSTIC OR TREATMENT OUTCOME. THERE WERE NO REPORTS OF PATIENT HARM. THIS EVENT REQUIRES 12 REPORTS. RELATED PATIENT IDENTIFIERS FOR THE FIRST COMBINATION OF DEVICES USED ARE AS FOLLOWS: (B)(6) (WA00014A / HF-CABLE, BIPOLAR) (B)(6) (WA00014A / HF-CABLE, BIPOLAR) (B)(6) (A42011A / RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS) (B)(6) (A42021A / OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE) (B)(6) (WA22366A /WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE) (B)(6) (WB50402W / FOOT SWITCH, DOUBLE, FOR, ESG-400). RELATED PATIENT IDENTIFIERS FOR THE SECOND COMBINATION OF DEVICES USED: (B)(6) (WB50402W / FOOT SWITCH, DOUBLE, FOR, ESG-400) (B)(6) (WA22366A / WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE) (B)(6) (A42011A / RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371127 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AT THE END OF ENDOSCOPIC SURGERY FOR TRANSURETHRAL RESECTION FOR PROSTATIC ADENOMA (WEIGHING AROUND 50 GM) A VIOLENT INTRAVESICAL EXPLOSION OF A PROBABLE GASEOUS NATURE OCCURRED DURING THE USE OF CLOT CURRENT. THE PROCEDURE WAS IMMEDIATELY STOPPED, AND EXPLORATORY LAPAROTOMY WAS REQUIRED, REVEALED ENDO PERITONEAL LACERATION OF THE BLADDER. REPORTEDLY, THE BLADDER WAS COMPLETELY RUPTURED WITH BLEEDING AND INTRAVESICAL DISPLACEMENT OF INTESTINAL LOOPS WITH SOME ECCHYMOSIS. AS SUCH, COMPLEX EXPLORATORY SURGERY WAS PERFORMED TO REPAIR THE BLADDER. POST SURGERY, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER CARE. UPON FOLLOW-UP NO ADDITIONAL INFORMATION COULD BE RECEIVED REGARDING THE PATIENT'S CURRENT CONDITION. THERE WAS 6 DEVICES INVOLVED IN THIS EVENT REPORTED UNDER THE FOLLOWING PATIENT IDENTIFIERS: RELATED PATIENT IDENTIFIER # (B)(6), HF UNIT "ESG-400", MODEL- A42021A, SERIAL # (B)(6). RELATED PATIENT IDENTIFIER # (B)(6), OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE, MODEL- WA2T430A, SERIAL #(B)(6) (THIS REPORT). RELATED PATIENT IDENTIFIER # (B)(6), TELESCOPE "OES ELITE", 4 MM, 30°, HD, AUTOCLAVABLE, MODEL- WA2T430A SERIAL #

  Patient problems: Ecchymosis; Hemorrhage/Blood Loss/Bleeding; Laceration(s); Rupture; Unspecified Gastrointestinal Problem

  MAUDE report 17313109 ↗