Olympus PK-CF0533Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00821925035867), received between Jan 8, 2021 and Aug 23, 2024 — classified as 20 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Output Problem” (15 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K203277); 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-1640-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Dec 15, 2023Open, Classified

   The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

   Z-1167-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THE SUBJECT DEVICE SHOWED SOMETIMES A SHORT CIRCUIT. THE GENERATOR WAS CHANGED AND THAT DIDN'T WORK; THE PROCEDURE WAS COMPLETED ONCE THE SUBJECT DEVICE WAS CHANGED WITH A SIMILAR DEVICE. THE ISSUE OCCURRED DURING A GYNECOLOGY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052134 ↗
• MalfunctionAug 21, 2024Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THE SUBJECT DEVICE SOMETIMES SHOWED A SHORT CIRCUIT. THE GENERATOR WAS CHANGED AND THAT DIDN'T WORK; THE PROCEDURE WAS COMPLETED ONCE THE SUBJECT DEVICE WAS CHANGED WITH A SIMILAR DEVICE. THE ISSUE OCCURRED DURING A GYNECOLOGY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20019943 ↗
• MalfunctionAug 19, 2024Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THE SUBJECT DEVICE SHOWED SOMETIMES A SHORT CIRCUIT. THE GENERATOR WAS CHANGED AND THAT DIDN'T WORK; THE PROCEDURE WAS COMPLETED ONCE THE SUBJECT DEVICE WAS CHANGED WITH A SIMILAR DEVICE. THE ISSUE OCCURRED DURING A GYNECOLOGY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000357 ↗
• InjuryJul 10, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, ONE OF THE JAWS ON THE CUTTING FORCEPS BROKE INSIDE THE PATIENT. THE JAW HAS BEEN RECOVERED. THE ISSUE OCCURRED DURING A HYSTERECTOMY UNDER COELIO PROCEDURE THAT CAUSED A FIFTEEN-MINUTE EXTENSION. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713364 ↗
• MalfunctionDec 19, 2023No Device Output; No Device Output

  THE CUSTOMER REPORTED TO OLYMPUS, THE PK CUTTING FORCEPS, CLAMP WAS NOT WORKING. SINCE THE CLAMP WAS NOT COAGULATING AND NO SCREEN ERROR WAS SHOWN, THE CLAMP WAS REPLACED WITH ANOTHER CLAMP OF THE SAME MODEL (PK-CF0533). THE CLAMP WAS CHANGED IMMEDIATELY SO IT WAS NOT NECESSARY TO EXTEND THE PROCEDURE AND THE PATIENT´S CONDITION WAS NOT AFFECTED BY THE REPORTED FAILURE. THE ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360841 ↗
• InjuryNov 30, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT WHEN USING A PK CUTTING FORCEPS, 5MM, 3CM, THE JAWS FELL APART INSIDE THE PATIENT DURING THERAPEUTIC LAPAROSCOPIC TOTAL HYSTERECTOMY SURGERY. THE BROKEN PIECE WAS RETRIEVED BY THE USER. THERE WAS NO PATIENT HARM REPORTED WITH THE EVENT. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT NOT PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242587 ↗
• InjuryOct 17, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN UNKNOWN PROCEDURE, THE PK-CF0533- PK, CUTTING FORCEPS BROKE OFF. THE BRANCH WAS REMOVED FROM THE "SITUS" IMMEDIATELY. NO COMPLICATIONS WERE REPORTED. ADDITIONAL FOLLOW-UP WITH THE CUSTOMER WAS CONDUCTED AND NO FURTHER DETAILS ABOUT THE PROCEDURE OR PATIENT OUTCOME WERE PROVIDED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949365 ↗
• InjuryAug 15, 2023Break; Break

  ADDITIONAL INFORMATION IDENTIFIED THAT THE FALLEN PART OF THE CLAMP PK-CF0533 WAS THE PROBE. THE FALLEN PROBE WAS EXTRACTED FROM THE PATIENT'S BODY WITH A CLAMP. THE PROCEDURE WAS NOT PROLONGED. NO MEDICAL INTERVENTIONS WERE PERFORMED AND NO PROLONGED HOSPITALIZATION. REPORTEDLY, THE PATIENT IS RECOVERING FINE AFTER THE INCIDENT. NO PATIENT ADVERSE EFFECTS WERE REPORTED. THE PATIENT HAS NO RELEVANT PRE-EXISTING MEDICAL CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548636 ↗
• InjuryAug 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN UNSPECIFIED THERAPEUTIC GYNE PROCEDURE USING THE CUTTING FORCEPS, ONE OF THE JAWS BROKE WHILE INSIDE THE PELVIC CAVITY. THE DEVICE WAS WITHDRAWN AND BROKEN PIECE WAS RETRIEVED AND CHECKED FOR COMPLETENESS. THE PELVIC CAVITY WAS CHECKED AND THERE WAS NO RETAINED FRAGMENTS. THE PROCEDURE DELAYED FOR FIVE MINUTES AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542009 ↗
• MalfunctionAug 8, 2023Failure to Seal; Failure to Seal

  THE CUSTOMER REPORTED THAT CUTTING FORCEPS DO NOT SEAL PROPERLY, WHEN GRASPING THE FABRIC, THE DEVICE DID NOT WORK PROPERLY. THE ISSUE WAS FOUND AT THE BEGINNING OF A THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482419 ↗
• InjuryJul 27, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A GYNECOLOGICAL SURGERY, WHEN USING THE FORCEPS TO COAGULATE AND CUT, ONE OF THE BLADES OF THE JAW WAS BROKEN AND WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE BY LAPAROSCOPIC INTERVENTION. CUSTOMER REPORTED THE SAME ISSUE HAPPENED IN DIFFERENT PROCEDURE. THE PHYSICIAN HAD THE IMPRESSION THAT THE DEVICES ARE NOW SOFTER THAN BEFORE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIERS: (B)(6) - 1 OF 2 PROCEDURES. (B)(6) - 2 OF 2 PROCEDURES. THIS REPORT IS FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410408 ↗
• InjuryJul 27, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A GYNECOLOGICAL SURGERY, WHEN USING THE FORCEPS TO COAGULATE AND CUT, ONE OF THE BLADES OF THE JAW WAS BROKEN AND WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE BY LAPAROSCOPIC INTERVENTION. CUSTOMER REPORTED THE SAME ISSUE HAPPENED IN A DIFFERENT PROCEDURE. THE PHYSICIAN HAD THE IMPRESSION THAT THE DEVICES ARE NOW SOFTER THAN BEFORE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIERS: (B)(6) - 1 OF 2 PROCEDURES. (B)(6) - 2 OF 2 PROCEDURES. THIS REPORT IS FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410371 ↗
• InjuryJun 28, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY PROCEDURE, ONE OF THE TIPS OF THIS CUTTING FORCEPS BROKE OFF INSIDE THE PATIENT. THE DEVICE WAS BEING USED TO CAUTERIZE AND CUT THE UTERINE VESSELS. THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN TIP. NO UNEXPECTED OR PROLONGED CARE, NO PROCEDURE DELAY, AS REPORTED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION DONE. THE DEVICE WAS INSPECTED BEFORE USE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17222293 ↗
• MalfunctionJun 27, 2023Output Problem; Output Problem

  THE SURGEON AT THE USER FACILITY REPORTED THAT DURING A LAPAROSCOPIC BILATERAL SALPINGECTOMY, THE PLASMAKINETIC CUTTING FORCEPS WERE ¿NOT CUTTING PROPERLY, EVEN WITH ADEQUATE AMOUNT OF TISSUE IN THE FORCEPS.¿ NO ERROR WAS DISPLAYED ON THE MACHINE AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. NO DELAY AND NO HARM OR IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17206324 ↗
• InjuryJun 22, 2023Break; Break

  A NURSE REPORTED TO OLYMPUS THAT DURING A LAPAROSCOPIC HYSTERECTOMY, ONE TO THE JAWS OF THIS CUTTING FORCEPS BROKE AND FELL INTO THE PATIENT'S ABDOMEN. THE BROKEN PART WAS RECOVERED FROM THE PATIENT'S BODY BUT LOST DURING CLEANING FOR EXPERTISE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17186512 ↗
• InjuryJun 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE PK CUTTING FORCEPS, 5 MM, 33CM BRANCH FELL OFF DURING PREPARATION OF THE UNIT. ADDITIONAL INFORMATION WAS LATER RECEIVED FROM THE CUSTOMER INDICATING THAT THE EVENT OCCURRED DURING A THERAPEUTIC LAPAROSCOPIC SUPRACERVICAL (LSC) HYSTERECTOMY AND LSC CHOLECYSTECTOMY. THE BRANCH WAS FOUND IMMEDIATELY. THE PROCEDURE WAS PROLONGED BY 10-MINUTES WITH THE PATIENT UNDER GENERAL ANESTHESIA, AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131824 ↗
• InjuryJun 9, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC GYNECOLOGICAL PROCEDURE, REMOVAL OF THE UTERUS, USING AN HF UNIT "ESG-400" WITH THE PK CUTTING FORCEPS, 5MM, 33CM, THE DEVICES DID NOT FUNCTION AS DESIRED. CONSEQUENTLY, THE PROCEDURE WAS CONVERTED TO AN OPEN SURGERY, WHICH WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTEDLY FINE. THE ESG AND CUTTING TOOL WERE CHECKED PRIOR TO THE PROCEDURE AND NO ISSUES WERE NOTED. IT ALSO WORKED FINE THE FOLLOWING DAY WHEN IT WAS CHECKED. THE GAS WAS ALSO CHECKED OUTSIDE THE PATIENT. THE ESG WILL BE CHECKED BY A FIELD SERVICE INSPECTOR, AND AN OLYMPUS REPRESENTATIVE WILL OBSERVE FOR THE NEXT PROCEDURE AND HAVE ADDITIONAL REPLACEMENT TOOLS. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE HF UNIT "ESG-400". CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE PK CUTTING FORCEPS, 5MM, 33CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100836 ↗
• InjuryJun 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY, ONE BRANCH OF THE PK CUTTING FORCEPS, 5MM, 33CM FELL OUT OF THE SHAFT AND INTO THE PATIENT. THE DEVICE HAD TO BE REMOVED LAPAROSCOPICALLY WITH A FRANCE CLAMP. THIS TOOK AN ADDITIONAL 5 MINUTES WHILE A NEW DEVICE WAS INSTALLED. IT WAS ALSO STATED THAT THE DEVICE HAD NO ABNORMALITIES UPON INITIAL INSPECTION AND WORKED UNTIL ALMOST THE END OF THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099631 ↗
• InjuryApr 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A COMPANY REPRESENTATIVE, ON BEHALF OF A USER FACILITY, REPORTED TO OLYMPUS TWO INCIDENTS OF BREAKAGE THAT OCCURRED WHILE USING THE PK CUTTING FORCEPS, 5MM, 33CM. THIS PATIENT'S PROCEDURE WAS A THERAPEUTIC HYSTERECTOMY. THE PROCEDURE WAS DELAYED 30 MINUTES; IT WAS STATED THAT THERE WAS NO DETERIORATION IN THE PATIENT'S HEALTH STATE DUE TO THE DELAY. THE PART THAT FELL INSIDE OF THE PATIENT WAS RETRIEVED USING LAPAROSCOPIC FORCEPS WITHOUT CAUSING ANY INJURY TO THE PATIENT, NOR LEAVING ANY FRAGMENT/ PART INSIDE. THE PROCEDURE WAS COMPLETED WITH A NON-OLYMPUS FORCEPS. IT WAS STATED THAT THE DEFECTIVE FORCEPS WAS NOT USED TO PUSH ORGANS NOR ANY STRUCTURE DURING THE PROCEDURE, AND THAT THE USERS HAVE BEEN USING THE FORCEPS FOR FIVE YEARS AND CONSIDER THEMSELVES EXPERIENCED WITH ITS USE. THERE WAS NO ERROR ON THE GENERATOR. THE PATIENT EXPERIENCED NO INJURY OR HARM. PATIENT IDENTIFIER (B)(6) IS FOR THE FIRST INSTANCE OF BREAKAGE. PATIENT IDENTIFIER (B)(6) IS FOR THE SECOND INSTANCE OF BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765937 ↗
• InjuryApr 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A COMPANY REPRESENTATIVE, ON BEHALF OF A USER FACILITY, REPORTED TO OLYMPUS TWO INCIDENTS OF BREAKAGE THAT OCCURRED WHILE USING THE PK CUTTING FORCEPS, 5MM, 33CM. THIS PATIENT'S PROCEDURE WAS A THERAPEUTIC HYSTERECTOMY. THE PROCEDURE WAS DELAYED 30 MINUTES; IT WAS STATED THAT THERE WAS NO DETERIORATION IN THE PATIENT'S HEALTH STATE DUE TO THE DELAY. THE PART THAT FELL INSIDE OF THE PATIENT WAS RETRIEVED USING LAPAROSCOPIC FORCEPS WITHOUT CAUSING ANY INJURY TO THE PATIENT, NOR LEAVING ANY FRAGMENT/ PART INSIDE. THE PROCEDURE WAS COMPLETED WITH A NON-OLYMPUS FORCEPS. IT WAS STATED THAT THE DEFECTIVE FORCEPS WAS NOT USED TO PUSH ORGANS NOR ANY STRUCTURE DURING THE PROCEDURE, AND THAT THE USERS HAVE BEEN USING THE FORCEPS FOR FIVE YEARS AND CONSIDER THEMSELVES EXPERIENCED WITH ITS USE. THERE WAS NO ERROR ON THE GENERATOR. THE PATIENT EXPERIENCED NO INJURY OR HARM.PATIENT IDENTIFIER C23157380 IS FOR THE FIRST INSTANCE OF BREAKAGE.PATIENT IDENTIFIER C23152173 IS FOR THE SECOND INSTANCE OF BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765911 ↗
• InjuryApr 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A COMPANY REPRESENTATIVE, ON BEHALF OF A USER FACILITY, REPORTED TO OLYMPUS THAT DURING AN ONCOLOGICAL HYSTERECTOMY PROCEDURE WHILE USING THE PK CUTTING FORCEPS, 5MM, 33CM SPECIFICALLY WHEN TAKING THE TISSUE AT THE START OF THE SURGERY, THE JAW OF THE FORCEPS BROKE AND LEFT A PIECE INSIDE THE PATIENT. THE PROCEDURE WAS DELAYED 30 MINUTES; IT WAS STATED THAT THERE WAS NO DETERIORATION IN THE PATIENT'S HEALTH STATE DUE TO THE DELAY. THE PART THAT FELL INSIDE OF THE PATIENT WAS RETRIEVED USING LAPAROSCOPIC REUSABLE FORCEPS WITHOUT CAUSING ANY INJURY TO THE PATIENT, NOR LEAVING ANY FRAGMENT/ PART INSIDE. THE PROCEDURE WAS COMPLETED WITH A NON-OLYMPUS FORCEPS. IT WAS STATED THAT THE DEFECTIVE FORCEPS WAS NOT USED TO PUSH ORGANS NOR ANY STRUCTURE DURING THE PROCEDURE, AND THAT THE USERS HAVE BEEN USING THE FORCEPS FOR FIVE YEARS AND CONSIDER THEMSELVES EXPERIENCED WITH ITS USE. THERE WAS NO ERROR ON THE GENERATOR. THE PATIENT EXPERIENCED NO INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765436 ↗
• MalfunctionFeb 27, 2023Intermittent Energy Output; Intermittent Energy Output

  AS REPORTED, AN INCONSISTENT CAUTERIZATION WITH FREQUENT REAPPLYING AND ATTEMPTS REQUIRED WAS OBSERVED ON THE DEVICE. NO OTHER DEVICES CONNECTED TO THE DEVICE WHEN THE REPORTED PROBLEM WAS OBSERVED. ACCORDING TO THE REPORT, THE ISSUE OCCURRED DURING A THERAPEUTIC LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY (LAPAROSCOPIC BSO) PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH NO IMPACT OR HARM TO THE PATIENT. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449578 ↗
• MalfunctionJan 27, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE SUBJECT DEVICE WAS NOT RECOGNIZED BY THE GENERATOR WHEN IT WAS PLUGGED IN. ANOTHER GENERATOR WAS TRIED WITH THE SAME RESULT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, ERROR CODE E619-DATA TRANSFER OCCURRED WHEN THE COAGULATION SWITCH WAS PRESSED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (ERROR CODE E619).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16257139 ↗
• InjuryJan 12, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT THE TOP JAW OF THE CUTTING FORCEPS BROKE OFF AND FELL INTO THE PATIENT DURING A LAPAROSCOPIC HYSTERECTOMY. THE PHYSICIAN INDICATED THAT THE FORCEPS WAS USED TO DO MODEST DISSECTION INTO THE FIBROTIC TISSUES SEEN TYPICALLY AROUND THE UTERINE ARTERIES AND THAT THE FORCEPS WERE "TOO FLIMSY". THE BROKEN PIECE WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SIMILAR DEVICE. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154044 ↗
• InjuryJan 12, 2023Break; Break

  IT WAS CONFIRMED BY THE FACILITY THAT THE DEVICES WERE INSPECTED PRIOR TO USE WITH NO ABNORMALITIES OBSERVED. PATIENT DEMOGRAPHICS ARE UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153986 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203277. One submission often covers many models, so check the product and lot details in each record.

• Z-2339-2025 · Jul 25, 2025 · Open, Classified
  Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical g
• Z-2415-2024 · Jun 21, 2024 · Open, Classified
  ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries M