Gyrus ACMI HACF0533Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00821925036390), received between Aug 25, 2021 and Jan 28, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Output Problem” (4 reports).

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

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 18, 2026.

Recalls naming this device

1. Feb 25, 2026Class IIOpen, 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-1641-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026No Device Output

  IT WAS REPORTED THE HALO CUTTING FORCEPS INSTRUMENT APPEARED TO NOT GET POWER. THE ISSUE WAS FOUND DURING A LAPAROSCOPIC THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199849 ↗
• MalfunctionJan 9, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THE HALO CUTTING FORCEPS HAD FLOATING PIECE OF BLACK PLASTIC INSIDE THE SEALED PACKAGING. THE ISSUE WAS FOUND UPON RECEIPT OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022785 ↗
• MalfunctionJan 9, 2026Manufacturing, Packaging or Shipping Problem

  NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022519 ↗
• MalfunctionAug 20, 2025Material Integrity Problem; Material Integrity Problem

  ON 14AUG2025 - (B)(6) - TAC : THE CUSTOMER (B)(6) REPORTED TO OLYMPUS REPRESENTATIVE (B)(4) THAT THE HACF0533 HALO HAD A DULL BLADE AND DID NOT CUT TISSUE. THE CUSTOMER SWAPPED THE BLADE OUT AND WAS ABLE TO CUT TISSUE. THE CUSTOMER DOES NOT HAVE THE HACF0533 BLADE TO RETURN FOR INSPECTION. IT WAS REPORTED THE HALO CUTTING FORCEPS HAD A DULL BLADE AND DID NOT CUT TISSUE. THE CUSTOMER SWAPPED THE BLADE OUT AND WAS ABLE TO CUT TISSUE. THE MALFUNCTION OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852057 ↗
• MalfunctionJul 25, 2025Output Problem; Output Problem

  IT WAS REPORTED THE SUBJECT DEVICE STOPPED WORKING WHILE IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608353 ↗
• MalfunctionSep 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE HALO PACKS CUTTING FORCEPS JAW WOULD NOT LET GO OF THE TISSUES. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135107 ↗
• MalfunctionDec 1, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALO PKS CUTTING FORCEPS,5MM/33CM HAD THE STERILE PACKING COMPROMISED UPON DELIVERY. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245742 ↗
• MalfunctionNov 2, 2023Power Problem; Power Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALO PKS CUTTING FORCEPS,5MM/33CM HAD NO POWER. THE EVENT OCCURRED DURING A THERAPEUTIC LAPAROSCOPIC TUBAL LIGATION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057115 ↗
• MalfunctionOct 23, 2023Power Problem; Power Problem

  THE CUSTOMER REPORTED THAT HIS OLYMPUS HALO CUTTING FORCEPS FAILED DURING A LAPAROSCOPIC BILATERAL TUBAL LIGATION BTL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE UNIT HAD NO POWER TO THE HAND PIECE. REPORTEDLY, THE USER HEARD A NOISE, BUT THE UNIT HAD NO OUTPUT. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985488 ↗
• MalfunctionJul 21, 2023Failure to Conduct; Failure to Conduct

  THE CUSTOMER REPORTED TO OLYMPUS, THE HALO PKS CUTTING FORCEPS, ARE NOT CONDUCTING ANY CAUTERY, AND THE INSTRUMENT IS NOT FIRING AT ALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374709 ↗
• MalfunctionMar 2, 2023Energy Output Problem; Energy Output Problem

  OLYMPUS REPRESENTATIVE IN BEHALF OF THE CUSTOMER REPORTED THAT THE DEVICE DID NOT SEAL TISSUE ALL THE WAY WHEN USED. THE ISSUE OCCURRED DURING A THERAPEUTIC LAPAROSCOPIC SALPINGECTOMY PROCEDURE. THE SUBJECT DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. IN A FOLLOW UP COMMUNICATION WITH THE CUSTOMER, IT WAS STATED THAT THE TOTAL LENGTH OF THE PROCEDURE WAS 31 MINUTES WITH NO HARM REPORTED OTHER THAN LONGER ANESTHESIA TO THE PATIENT AS THE USER NEED TO TROUBLESHOOT THE DEVICE AND HAD TO WAIT TO OPEN THE SECOND DEVICE. THE REPORTED PROBLEM ACCORDING TO THE CUSTOMER DID NOT AFFECT THE THERAPEUTIC OUTCOME OF THE PROCEDURE. NO HARM WAS REPORTED, NO PATIENT HARM , NO USER INJURY REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16465550 ↗
• MalfunctionDec 5, 2022Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  AS REPORTED BY THE HOSPITAL STAFF "THIS FORCEPS WAS MIS-FIRED DURING A PROCEDURE ON (B)(6)2022 WITH NO PATIENT INJURY REPORTED. IN A CALL COMMUNICATION WITH TECHNICAL ASSISTANCE CENTER (TAC) , THE REPORTER PROVIDED THE DEVICE MODEL , LOT NUMBER AND STATED "THERE IS NO REPORTED PATIENT INJURY DUE TO THE DEVICE WOULD NOT CLAMP DOWN". NO HARM, REPORTED, NO PATIENT , NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15919464 ↗
• MalfunctionSep 22, 2022Activation Failure; Activation Failure

  WHILE ONSITE AT THE FACILITY, THE OLYMPUS ACCOUNT MANAGER OBSERVED THE HACF0533 HALO CUTTING FORCEPS DID NOT ACTIVATE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ACCEPTABLE OUTCOME. THE PROCEDURE AND TYPE WERE UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THE EVENT. THIS WAS 1 OF 3 CUTTING FORCEPS THAT FAILED DURING THE PROCEDURE. RELATED REPORTS INCLUDE THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465463 ↗
• MalfunctionSep 22, 2022Activation Failure; Activation Failure

  WHILE ONSITE AT THE FACILITY, THE OLYMPUS ACCOUNT MANAGER OBSERVED THE HACF0533 HALO CUTTING FORCEPS DID NOT ACTIVATE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ACCEPTABLE OUTCOME. THE PROCEDURE AND TYPE WERE UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THE EVENT. THIS WAS 1 OF 3 CUTTING FORCEPS THAT FAILED DURING THE PROCEDURE. RELATED REPORTS INCLUDE THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465449 ↗
• MalfunctionSep 22, 2022Activation Failure; Activation Failure

  WHILE ONSITE AT THE FACILITY, THE OLYMPUS ACCOUNT MANAGER OBSERVED THE HACF0533 HALO CUTTING FORCEPS DID NOT ACTIVATE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ACCEPTABLE OUTCOME. THE PROCEDURE AND TYPE WERE UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THE EVENT. THIS WAS 1 OF 3 CUTTING FORCEPS THAT FAILED DURING THE PROCEDURE. RELATED REPORTS INCLUDE THE FOLLOWING PATIENT IDENTIFIERS:(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465312 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "VAGINAL NATURAL ORIFICE TRANSVAGINAL ENDOSCOPIC SURGERY (VNOTES) SURGICAL STAGING FOR ENDOMETRIAL CARCINOMA: THE FEASIBILITY OF AN INNOVATIVE APPROACH". LITERATURE SUMMARY: THE AIM OF THIS SINGLE CENTER, RETROSPECTIVE, LONGITUDINAL STUDY OF PROSPECTIVELY REGISTERED PATIENTS WAS TO DESCRIBE THE EXPERIENCE OF STAGING SURGERY FOR EARLY-STAGE ENDOMETRIAL CARCINOMA IN 15 WOMEN WHO UNDERWENT VNOTES TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND SENTINEL LYMPH NODE BIOPSY/PELVIC LYMPH NODE DISSECTION. THE PRIMARY OUTCOMES ASSESSED WERE THE MEAN OPERATION TIME, THE AVERAGE BLOOD LOSS AND BMI OF PATIENTS, THE NUMBER OF SLN BIOPSIED, AND THE HISTOPATHOLOGICAL POSITIVITY AND EXTENT OF TUMOR INVASION. THE AVERAGE OPERATIVE TIME WAS 231.4 MIN (SD 41.0) WITH THE MEAN ESTIMATED BLOOD LOSS OF 122.0 ML (SD 104.4). THERE WAS ONE CASE WITH THE SURGICAL COMPLICATION OF BLADDER INJURY REQUIRING CONVERSION TO CONVENTIONAL LAPAROSCOPY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS BLADDER PERFORATION(1). SINCE THE LITERATURE DESCRIBED "PKS CUTTING FORCEPS", WE SELECTED "HACF0533" AS A REPRESENTATIVE PRODUCT.

  Patient problems: Internal Organ Perforation

  MAUDE report 14634268 ↗
• MalfunctionOct 28, 2021Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  AS REPORTED, THE USER REPORTED HAVING AN INTERMITTENT ACTIVATION ISSUE WITH THE DEVICE. SOMETIMES WHEN PRESSES THE BUTTON ON THE HANDPIECE TO ACTIVATE THE COAGULATION, THERE WOULD BE NO ENERGY COMING OUT. THE USER SWITCHES OVER TO ANOTHER HALO HANDPIECE FROM THE SAME BOX TO CONTINUE WITH THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED. THE ISSUE OCCURRED DURING A LAPAROSCOPIC BILATERAL SALPINGECTOMY. THERE WAS NO PATIENT IMPACT OR HARM ON THIS REPORTED EVENT. NO USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712976 ↗
• MalfunctionSep 21, 2021Output Problem; Intermittent Energy Output; Output Problem; Intermittent Energy Output

  AS REPORTED, THE USER WAS USING THE HACF0533 DURING A BILATERAL LAPAROSCOPIC SALPINGECTOMY PROCEDURE AND THE HALO FORCEPS WERE ONLY WORKING INTERMITTENTLY. THE USER USED A SECOND HALO DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509883 ↗
• MalfunctionSep 2, 2021No Device Output; Defective Device; No Device Output; Defective Device

  AS REPORTED, THE DEVICE HAS FAILED, THE DEVICE DID NOT COAGULATE AT ALL. ANOTHER SAME LIKE DEVICE FROM THE SAME BOX WAS USED AND THE PROCEDURE WAS ABLE TO BE COMPLETED. THE ISSUE OCCURRED IN THE BEGINNING OF A HYSTERECTOMY PROCEDURE. NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12417725 ↗
• MalfunctionAug 25, 2021Output Problem; Output Problem

  AS REPORTED, AN INVALID INSTRUMENT ERROR ON TWO ATTACHMENT HANDPIECES HACF0533 WITH IDENTICAL LOT NUMBER FR119455 WAS REPORTED. THE USER USED A DIFFERENT LOT NUMBER OF THE SAME INSTRUMENT TYPE WITHOUT ANY MORE PROBLEM. THE LOT NUMBER USED TO COMPLETE THE PROCEDURE WAS NOT PROVIDED. THE PROCEDURE WAS ABLE TO START AND COMPLETE WITHOUT ANY MORE INCIDENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368632 ↗
• MalfunctionAug 25, 2021Output Problem; Output Problem

  AS REPORTED, AN INVALID INSTRUMENT ERROR ON TWO ATTACHMENT HANDPIECES HACF0533 WITH IDENTICAL LOT NUMBER FR119455 WAS REPORTED. THE USER USED A DIFFERENT LOT NUMBER OF THE SAME INSTRUMENT TYPE WITHOUT ANY MORE PROBLEM. THE LOT NUMBER USED TO COMPLETE THE PROCEDURE WAS NOT PROVIDED. THE PROCEDURE WAS ABLE TO START AND COMPLETE WITHOUT ANY MORE INCIDENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368615 ↗