OLYMPUS 3006Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00821925035898), received between Feb 23, 2021 and Jan 8, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (10 reports).

2 FDA recall records name this device's identifier, 2 still open.

6 other recalls cover devices cleared under the same FDA submission (K023492); 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.

Recalls naming this device

1. Feb 25, 2026Open, Classified

   Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

   Z-1639-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Jul 1, 2024Open, Classified

   Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

   Z-2542-2024 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2024Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE CUTTING FORCEPS HAD A POTENTIAL OUT OF BOX FAILURE UPON INITIAL USE (THERE WAS NO NTOME FOR THE SEAL). THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE JAWS WERE UNRESPONSIVE TO MANIPULATION OF THE HANDLE AND REMAINED CLOSED WITHOUT OPENING. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18467530 ↗
• MalfunctionDec 27, 2023Device Damaged Prior to Receipt by User; Defective Component; Device Damaged Prior to Receipt by User; Defective Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE CUT/FCP, 5MM/33CM DES III (05/PK) WAS REPORTED TO FAIL UPON INSTALLATION; THE STERILE PACKAGE WAS COMPROMISED. THE BOTTOM TAB WAS BROKEN OFF, AND THE OTHER WAS CRIMPED IN. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6) TO CAPTURE THE TWO OTHER STERILE PACKAGES THAT WERE COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401301 ↗
• MalfunctionDec 27, 2023Device Damaged Prior to Receipt by User; Defective Component; Device Damaged Prior to Receipt by User; Defective Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE CUT/FCP, 5MM/33CM DES III (05/PK) WAS REPORTED TO FAIL UPON INSTALLATION; THE STERILE PACKAGE WAS COMPROMISED. THE BOTTOM TAB WAS BROKEN OFF, AND THE OTHER WAS CRIMPED IN. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6) TO CAPTURE THE TWO OTHER STERILE PACKAGES THAT WERE COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401250 ↗
• MalfunctionDec 27, 2023Device Damaged Prior to Receipt by User; Defective Component; Device Damaged Prior to Receipt by User; Defective Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE CUT/FCP, 5MM/33CM DES III (05/PK) WAS REPORTED TO FAIL UPON INSTALLATION; THE STERILE PACKAGE WAS COMPROMISED. THE BOTTOM TAB WAS BROKEN OFF, AND THE OTHER WAS CRIMPED IN. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6) AND (B)(6) TO CAPTURE THE TWO OTHER STERILE PACKAGES THAT WERE COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400935 ↗
• MalfunctionMay 3, 2023Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Unsealed Device Packaging; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THE STERILE PACKAGING OF ITEM NUMBER 3006 WAS FOUND OPENED DURING PREPARATION OF THE PROCEDURE. THE DEVICE WAS NEVER USE ON THE PATIENT. THE DEVICE WAS REPLACED AND THE INTENDED AN UNSPECIFIED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861290 ↗
• MalfunctionNov 4, 2022Packaging Problem; Packaging Problem

  THE CUSTOMER REPORTED TO OLYMPUS WHILE PREPARING FOR USE, THE CUT/FCP,5MM/33CM DES III (5/PK) TAKEN OUT OF THE CASE AND THE EDGE IS DAMAGED AND EXPOSED TO AIR. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735217 ↗
• MalfunctionOct 23, 2022Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE DEVICE DURING AN UNSPECIFIED PROCEDURE DID NOT SEEM TO CAUTERIZE AS EFFICIENTLY TO STOP BLEEDING. THE DEVICE AT THE TIME OF THE EVENT IS BEING USED WITH A THIRD PARTY GENERATOR ( VALLEYLAB FT10). THE PROCEDURE WAS COMPLETED WITH A COMPLETELY DIFFERENT SET OF EQUIPMENT, WITH SIMILAR DEVICE AND WITH NO FURTHER ISSUES. NO DELAY IN THE PROCEDURE WAS REPORTED. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656413 ↗
• MalfunctionAug 11, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER REPORTED THE INNER AND OUTER PACKAGING ON THE SUBJECT DEVICE WAS DAMAGED WHEN IT WAS RECEIVED. THE DEVICE WAS ALSO BROKEN IN THE PACKAGE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15211675 ↗
• MalfunctionJul 5, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THE DEVICE MODEL 3006 5MM CUTTING FORCEPS WAS REPORTED TO FAIL UPON INSTALLATION. CUSTOMER REPORTED THEY WERE PERFORMING INVENTORY AND FOUND THE CORNER OF THE AREA OF THE 3006 PACKAGE IS FOLDED UPWARD INSIDE THE BOX AND THERE IS TINY CRACK, RENDERING IT UNSTERILE. CUSTOMER STATED THEY HAVE SEEN THIS OCCURRED WITH TWO (2) OTHER ONES 2-3 WEEKS AGO PRIOR TO THIS REPORT. CUSTOMER STATED THE TWO ADDITIONAL ITEMS WERE NEVER USED ON A PATIENT, AND WERE DISCARDED AND NON WERE REPORTED. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT INCLUDES 4 REPORTS (CUSTOMER REPORTED WITH THE SAME ISSUE (DAMAGED PACKAGING) . C22219348 (LOT FR200177) DAMAGED PACKAGING. C22219092 (LOT FR179557) DAMAGED PACKAGING. C22228637 (UNKNOWN LOT) DEVICE DISCARDED BY THE CUSTOMER, THE ISSUE WAS NOT REPORTED TO OLYMPUS AT TIME OF THE EVENT. C22228636 (UNKNOWN LOT) DEVICE DISCARDED BY THE CUSTOMER, THE ISSUE WAS NOT REPORTED TO OLYMPUS AT TIME OF THE EVENT. THIS REPORT IS FOR REPORT PATIENT IDENTIFIER C22228636 (UNKNOWN LOT) DEVICE DISCARDED BY THE CUSTOMER, THE ISSUE WAS NOT REPORTED TO OLYMPUS AT TIME OF THE EVENT (DAMAGED PACKAGING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14921644 ↗
• MalfunctionJul 5, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  HOLD AP 10.12 IT WAS REPORTED THE DEVICE MODEL 3006 5MM CUTTING FORCEPS WAS REPORTED TO FAIL UPON INSTALLATION. CUSTOMER REPORTED THEY WERE PERFORMING INVENTORY AND FOUND THE CORNER OF THE AREA OF THE 3006 PACKAGE IS FOLDED UPWARD INSIDE THE BOX AND THERE IS TINY CRACK, RENDERING IT UNSTERILE. CUSTOMER STATED THEY HAVE SEEN THIS OCCURRED WITH TWO (2) OTHER ONES 2-3 WEEKS AGO PRIOR TO THIS REPORT. CUSTOMER STATED THE TWO ADDITIONAL ITEMS WERE NEVER USED ON A PATIENT, AND WERE DISCARDED AND NON WERE REPORTED. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT INCLUDES 4 REPORTS (CUSTOMER REPORTED WITH THE SAME ISSUE (DAMAGED PACKAGING). (B)(6) (LOT FR200177) DAMAGED PACKAGING. (B)(6) (LOT FR179557) DAMAGED PACKAGING. (B)(6) (UNKNOWN LOT) DEVICE DISCARDED BY THE CUSTOMER, THE ISSUE WAS NOT REPORTED TO OLYMPUS AT TIME OF THE EVENT. (B)(6) (UNKNOWN LOT) DEVICE DISCARDED BY THE CUSTOMER, THE ISSUE WAS NOT REPORTED TO OLYMPUS AT TIME OF THE EVENT. THIS REPORT IS FOR REPORT PATIENT IDENTIFIER (B)(6) (UNKNOWN LOT) DEVICE DISCARDED BY THE CUSTOMER, THE ISSUE WAS NOT REPORTED TO OLYMPUS AT TIME OF THE EVENT (DAMAGED PACKAGING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14921602 ↗
• MalfunctionJul 5, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THE DEVICE MODEL: 3006 5MM CUTTING FORCEPS WAS REPORTED TO FAIL UPON INSTALLATION. CUSTOMER REPORTED THEY WERE PERFORMING INVENTORY AND FOUND THE CORNER OF THE AREA OF THE 3006 PACKAGE IS FOLDED UPWARD INSIDE THE BOX AND THERE IS TINY CRACK, RENDERING IT UNSTERILE. CUSTOMER STATED THEY HAVE SEEN THIS OCCURRED WITH TWO (2) OTHER ONES 2-3 WEEKS AGO PRIOR TO THIS REPORT. CUSTOMER STATED THE TWO ADDITIONAL ITEMS WERE NEVER USED ON A PATIENT, AND WERE DISCARDED AND NON WERE REPORTED. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT INCLUDES 4 REPORTS (CUSTOMER REPORTED WITH THE SAME ISSUE (DAMAGED PACKAGING) . (B)(6) (LOT: FR200177) DAMAGED PACKAGING. (B)(6) (LOT: FR179557) DAMAGED PACKAGING. (B)(6) (UNKNOWN LOT) DEVICE DISCARDED BY THE CUSTOMER, THE ISSUE WAS NOT REPORTED TO OLYMPUS AT TIME OF THE EVENT. (B)(6) (UNKNOWN LOT) DEVICE DISCARDED BY THE CUSTOMER, THE ISSUE WAS NOT REPORTED TO OLYMPUS AT TIME OF THE EVENT. THIS REPORT IS FOR REPORT PATIENT IDENTIFIER: (B)(6) (LOT: FR179557) DAMAGED PACKAGING..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14921553 ↗
• MalfunctionJul 5, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THE DEVICE MODEL 3006 5MM CUTTING FORCEPS WAS REPORTED TO FAIL UPON INSTALLATION. CUSTOMER REPORTED WHEN THEY UNPACKAGED THE BOX, THE CORNER OF THE AREA OF THE 3006 PACKAGE IS FOLDED UPWARD INSIDE THE BOX AND THERE IS TINY CRACK, RENDERING IT UNSTERILE. THEY HAVE ANOTHER ONE ON THE SHELF IN THE SAME CONDITION. CUSTOMER STATED THEY HAVE SEEN THIS OCCURRED WITH TWO (2) OTHER ONES 2-3 WEEKS AGO PRIOR TO THIS REPORT. CUSTOMER STATED THE TWO ADDITIONAL ITEMS WERE NEVER USED ON A PATIENT, AND WERE DISCARDED AND NON WERE REPORTED. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT INCLUDES 4 REPORTS (CUSTOMER REPORTED WITH THE SAME ISSUE (DAMAGED PACKAGING) . (B)(4) (LOT FR200177) DAMAGED PACKAGING. (B)(4) (LOT FR179557) DAMAGED PACKAGING. (B)(4) (UNKNOWN LOT) DEVICE DISCARDED BY THE CUSTOMER, THE ISSUE WAS NOT REPORTED TO OLYMPUS AT TIME OF THE EVENT. (B)(4) (UNKNOWN LOT) DEVICE DISCARDED BY THE CUSTOMER, THE ISSUE WAS NOT REPORTED TO OLYMPUS AT TIME OF THE EVENT. THIS REPORT IS FOR REPORT PATIENT IDENTIFIER (B)(4) (LOT FR200177) DAMAGED PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14921516 ↗
• MalfunctionNov 16, 2021Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  AS REPORTED. THE CORNERS OF BOTH THE OUTSIDE BOX AND THE INSIDE BOX WERE CRUSHED AND PUNCTURED. IT WAS REPORTED BY THE CUSTOMER THAT TWO OF THE 3006 CUTTING FORCEPS PACKAGES WERE DAMAGED AND THAT THEY WOULD BE RETURNING THE ENTIRE BOX AS A PRECAUTIONARY MEASURE. THE ISSUE FOUND DURING RECEIPT INSPECTION. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824527 ↗
• MalfunctionJun 30, 2021Communication or Transmission Problem; Communication or Transmission Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING A LAPAROSCOPIC EXCISION OF ENDOMETRIOSIS, THE DOCTOR ATTEMPTED TO USE A BIPOLAR CUTTING FORCEPS TO RESECT ENDOMETRIOSIS. THE EQUIPMENT WAS CONNECTED PER USUAL AND ALL CONNECTIONS WERE CHECKED. PEDAL-BIPOLAR WAS ATTACHED TO THE MACHINE AND WHEN ACTIVATED, IT PRODUCED A CONTINUOUS BEEPING SOUND BUT NO CAUTERY WAS OBTAINED. A SECOND BOVIE MACHINE WAS ATTEMPTED BUT THE EQUIPMENT WAS STILL UNABLE TO FUNCTION. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093907 ↗
• MalfunctionMar 15, 2021Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE DEVICE PACKAGING WAS DAMAGED. THE FORCEPS WERE NOT DAMAGED INSIDE THE PACKAGING . THE ISSUE OCCURRED DURING A RECEIPT INSPECTION. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11482294 ↗
• MalfunctionFeb 23, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE DEVICE FAILED. THE LOCKING MECHANISM WAS NOT WORKING. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE (SAME MODEL). THERE WAS NO PATIENT HARM OR INJURY REPORTED ON THIS EVENT. NO USER INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11367022 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023492. One submission often covers many models, so check the product and lot details in each record.

• Z-1642-2026 · Feb 25, 2026 · Open, Classified
  Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be pas
• Z-1644-2026 · Feb 25, 2026 · Open, Classified
  Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be p
• Z-1643-2026 · Feb 25, 2026 · Open, Classified
  Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended
• Z-1638-2026 · Feb 25, 2026 · Open, Classified
  Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bi
• Z-2541-2024 · Jul 1, 2024 · Open, Classified
  The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved u
• Z-2540-2024 · Jul 1, 2024 · Open, Classified
  The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved u