PK TECHNOLOGYRecalls & reported problems across all models
Gyrus ACMI, LLC · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one PK TECHNOLOGY model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 2
We found 10 models of PK TECHNOLOGY by Gyrus ACMI, LLC in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2020 and Aug 31, 2026 — classified as 3 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PK TECHNOLOGY recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · Recall details · FDA record ↗
- 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-1642-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported PK TECHNOLOGY problems
Device problems
- Break3
- Mechanical Problem3
- Energy Output Problem2
- Failure to Align2
- Output Problem2
- Activation Failure1
- Activation Problem1
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Burn(s)2
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
PK TECHNOLOGY models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PK TECHNOLOGY 920005PKELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall9 reports
- PK TECHNOLOGY 3005PKELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall2 reports
- PK TECHNOLOGY PK-SP0533ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- PK TECHNOLOGY 952005PKELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- PK TECHNOLOGY 910000PKELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- PK TECHNOLOGY 3000PKELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- PK TECHNOLOGY 3103PKELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- PK TECHNOLOGY 3600PKELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- PK TECHNOLOGY 942005PKELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- PK TECHNOLOGY 970010PCELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Recent PK TECHNOLOGY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Failure to Deliver Energy
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50520281 ↗MalfunctionApr 15, 2026Connection Problem
IT WAS REPORTED THE PK SPATULA CONNECTED TO THE GENERATOR WAS NOT RECOGNIZED AND DOES NOT FUNCTION. THE ISSUE WAS FOUND DURING A THERAPEUTIC HYSTERECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24888158 ↗MalfunctionAug 20, 2025Energy Output Problem; Energy Output Problem
IT WAS REPORTED THE SUBJECT DEVICE INSTRUMENT DID NOT WORK; IT COULD NOT ACTIVATE ENERGY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850323 ↗InjuryAug 19, 2025Break; Break
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22839163 ↗MalfunctionApr 22, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE ENCOUNTERED ARCING WHEN ACTIVATED. THE ISSUE OCCURRED DURING A THERAPEUTIC HYSTERECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21882722 ↗MalfunctionNov 1, 2023Loss of Power; Loss of Power
THE CUSTOMER REPORTED TO OLYMPUS THAT THE PKS CUTTING FORCEPS HAS NO ENERGY WHEN ACTIVATED AT FULL RANGE. THE ISSUE WAS FOUND DURING THE THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE WHICH WAS COMPLETED WITH NO DELAY AND WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18051832 ↗MalfunctionOct 25, 2023Unintended Power Up; Unintended Power Up
ADDITIONAL EVENT INFO. RECEIVED: THE PROCEDURE WAS A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY AND COMPLETED USING ANOTHER SPATULA DEVICE WITHOUT IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18003118 ↗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 26, 2022Output below Specifications; Output below Specifications
OLYMPUS RECEIVED A MEDWATCH REPORT MW5110616 REPORTED THAT THE BIPOLAR MACRO FORCEPS WORKED ONLY VERY MINIMALLY AND DID NOT COAGULATE AS NEEDED. REPORTER NOTED ON THE FORM "OUTPUT BELOW SPECIFICATIONS. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15105366 ↗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 ↗InjuryJun 30, 2022Break; Break
UPON FOLLOW UP FOR PATIENT IDENTIFIER (B)(6) INVOLVING A PATIENT BURNED WHEN SUBJECT DEVICE SPARKED, THE CUSTOMER REPORTED A SECOND EVENT. DURING THE WEEK OF (B)(6) 2022, THE SUBJECT DEVICE FELL APART IN THE PATIENT AND ALL PIECES WERE RETRIEVED. THE CUSTOMER REFUSED TO PROVIDE ADDITIONAL INFORMATION AND STATED THE EVENT WAS SUBMITTED VIA MEDSUN REPORT.
Patient problems: Burn(s); Foreign Body In Patient
MAUDE report 14877708 ↗
Other Gyrus ACMI, LLC products
- SOLTIVE16 models · 867 reports · 17 recalls
- Olympus27 models · 518 reports · 21 recalls
- SHOCKPULSE11 models · 580 reports · 5 recalls
- EZDilate7 models · 33 reports · 6 recalls
- Spiration Valve System10 models · 242 reports · 1 recall
- BiCOAG4 models · 36 reports · 5 recalls
- USA Elite24 models · 78 reports · 3 recalls
- M3 Gold5 models · 30 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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