PK TECHNOLOGY 920005PKRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00821925036178), received between May 6, 2021 and May 4, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 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-1644-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2023Material Twisted/Bent; Material Twisted/Bent

  OLYMPUS RECEIVED A REGULATORY COMPLAINT REPORT VIA EMAIL THAT A PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK) DEVICE HAD MALFUNCTIONED. THE JAWS WERE NOT CLOSING PROPERLY DURING A THERAPEUTIC LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH) PROCEDURE. THE PROCEDURE WAS COMPLETE WITH A SECOND SIMILAR DEVICE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE JAWS OF THE FORCEPS WERE BENT AND NOT ALIGNED PROPERLY. 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 16872824 ↗
• MalfunctionOct 19, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE DEVICE MODEL 920005PK WITH LOT FR207931 MALFUNCTIONED. THE " JAW NOT OPENING AND CLOSING PROPERLY". THE ISSUE FOUND DURING A THERAPEUTIC LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH) PROCEDURE. THE DEVICE WAS REPLACED WITH THE SAME MODEL (920005PK) WITH LOT NUMBER NOT PROVIDED AND THE INTENDED PROCEDURE WAS COMPLETED WITH NO PATIENT HARM OR ADVERSE EVENT REPORTED. THERE WAS NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15636234 ↗
• MalfunctionSep 9, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT, DURING A MYOMA PROCEDURE, THE SUBJECT DEVICE COULD NOT BE RECOGNIZED BY THE ELECTROSURGICAL UNIT MULTIPLE TIMES. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. IT WAS NOTED THAT THE USER HAS EXPERIENCE WITH THE DEVICE. THE SUBJECT DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, THE INSULATION WAS FOUND TO BE TORN. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (TORN INSULATION). THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396706 ↗
• MalfunctionJul 23, 2022Failure to Align; Failure to Align

  THE CUSTOMER REPORTED THE JAWS OF THE SUBJECT DEVICE WERE NOT CLOSING PROPERLY DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE JAW SYMMETRY WAS UNBALANCED AND THE JAWS WERE MISSHAPED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (JAWS NOT ALIGNED). THERE WAS NO EFFECT ON THE PATIENT OR USER DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090293 ↗
• MalfunctionJul 22, 2022Failure to Align; Failure to Align

  THE CUSTOMER REPORTED THE JAWS OF THE SUBJECT DEVICE WERE NOT CLOSING PROPERLY DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE JAW SYMMETRY WAS UNBALANCED AND THE JAWS WERE MISSHAPED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (JAWS NOT ALIGNED). THERE WAS NO EFFECT ON THE PATIENT OR USER DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089160 ↗
• MalfunctionJul 18, 2022Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close

  AS REPORTED, HANDPIECE NOT CLAMPING. CUSTOMER THEN STATED THAT THE HANDPIECE STARTED WORKING AND THEN THE JAWS BEGAN TO LOCK AND WOULD NOT OPEN. THE DEVICE WAS REPLACED. THE INTENDED PROCEDURE ( THERAPEUTIC BSO/HYSTERECTOMY- BILATERAL SALPINGO-OOPHORECTOMY) WAS COMPLETED WITH SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15043040 ↗
• MalfunctionApr 14, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED , CUSTOMER HAD FOUND HUMAN HAIR INSIDE THE SEALED PACKAGE WHILE DOING THE INITIAL INSPECTION. THERE IS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110124 ↗
• MalfunctionJun 18, 2021Defective Device; Fail-Safe Did Not Operate; Defective Device; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE CUTTING FORCEPS WOULD NOT OPEN UPON USING IT FOR THE FIRST TIME. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SECOND LIKE DEVICE. THE LOT/SERIAL NUMBER USED WAS NOT PROVIDED. THERE WAS NO PATIENT IMPACT OR HARM REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12025328 ↗
• MalfunctionMay 6, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SALPINGO-OOPHORECTOMY PROCEDURE THE HANDPIECE DEVICE WOULD NOT FIRE WHEN INSERTED THROUGH THE PORT TO CAUTERIZE A BLEED. AN UNKNOWN DELAY TO THE PROCEDURE WAS NOTED. THE INTENDED PROCEDURE HOWEVER WAS COMPLETED USING ANOTHER HANDPIECE. THE SERIAL NUMBER USED WAS NOT PROVIDED. THE EVENT ACCORDING TO THE REPORTER SLOWED DOWN THE PROCEDURE. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11785761 ↗

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-1639-2026 · Feb 25, 2026 · Open, Classified
  Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Ever
• 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-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-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-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
• 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-2542-2024 · 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