Strykeprobe 0250070443Recalls & reported problems
Stryker Corporation · Electrosurgical Probe, L-Tip · Class 2
All models of Strykeprobe (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker electrosurgical L-tip probe is used in laparoscopy and plastic surgery to cut and cauterize tissue. The 28 reports mostly describe the probe tip melting, arcing, sparking or catching fire, with damaged insulation sometimes burning the patient during surgery. Seven reports involve injuries, and no deaths are described. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07613327051872), received between Jul 26, 2018 and Apr 23, 2025 — classified as 7 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Melted” (7 reports).
3 other recalls cover devices cleared under the same FDA submission (K934094); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Melted7
- Arcing6
- Adverse Event Without Identified Device or Use Problem5
- Thermal Decomposition of Device5
- Material Deformation2
- Sparking2
- Temperature Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Insufficient Information7
- Burn(s)5
- Burn, Thermal5
- No Known Impact Or Consequence To Patient2
- Shock1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2025Sparking; Sparking
IT WAS REPORTED THAT THE DEVICE SPARKED.
Patient problems: Insufficient Information
MAUDE report 21890716 ↗MalfunctionNov 15, 2024Arcing; Temperature Problem; Arcing; Temperature Problem
IT WAS REPORTED THERE DAMAGED/COMPROMISED INSULATION AND ARCING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696060 ↗MalfunctionJul 3, 2024Arcing; Arcing
IT WAS REPORTED THAT THERE WAS DAMAGED/COMPROMISED INSULATION WHICH RESULTED IN PATIENT BURN. THE BURN OCCURRED IN THE UTERUS, WHICH WAS REMOVED AS PART OF THE HYSTEROSCOPY PROCEDURE, AND THEREFORE DID NOT RESULT IN PERMANENT IMPAIRMENT, IS NOT LIFE THREATENING, OR NECESSITATE UNPLANNED MEDICAL INTERVENTION.
Patient problems: Burn(s)
MAUDE report 19667812 ↗InjuryMay 23, 2024Arcing; Material Too Soft/Flexible; Arcing; Material Too Soft/Flexible
IT WAS REPORTED THE DEVICE ARCHED AND BURNED THE PATIENT REQUIRING A SUTURE TO REPAIR.
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 19384109 ↗MalfunctionMay 13, 2024Melted; Melted
IT WAS REPORTED THAT THE DEVICE CAUGHT FIRE. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES. THE DEVICE DID NOT CATCH FIRE INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19299059 ↗MalfunctionMay 13, 2024Melted; Melted
IT WAS REPORTED THAT THE DEVICE CAUGHT FIRE. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES. THE DEVICE DID NOT CATCH FIRE INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19298517 ↗MalfunctionSep 13, 2023Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT THERE WAS BREACH OF INSULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17739141 ↗MalfunctionSep 11, 2023Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT THERE WAS BREACH OF INSULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726526 ↗MalfunctionSep 11, 2023Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT THERE WAS BREACH OF INSULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726276 ↗MalfunctionSep 11, 2023Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT THERE WAS BREACH OF INSULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726274 ↗MalfunctionSep 11, 2023Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT THERE WAS BREACH OF INSULATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726213 ↗MalfunctionJul 24, 2023Electrostatic Discharge; Temperature Problem; Electrostatic Discharge; Temperature Problem
IT WAS REPORTED THAT THE USER WAS BURNED AND SHOCKED. THE BURN WAS MINOR AND DID NOT REQUIRE MEDICAL INTERVENTION.
Patient problems: Burn(s); Shock
MAUDE report 17385899 ↗MalfunctionSep 24, 2022Melted
IT WAS REPORTED THAT THE DEVICE MELTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15478592 ↗MalfunctionJul 21, 2022Melted
IT WAS REPORTED THAT THE DEVICE MELTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15073984 ↗MalfunctionJun 21, 2022Melted; Melted; Arcing
IT WAS REPORTED THAT THE DEVICE ARCED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14762528 ↗MalfunctionJun 21, 2022Material Deformation; Arcing; Material Deformation
IT WAS REPORTED THAT THE DEVICE ARCED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14762345 ↗MalfunctionApr 28, 2022Arcing; Sparking
IT WAS REPORTED THAT THE DEVICE ARCED/SPARKED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14240370 ↗MalfunctionApr 18, 2022Overheating of Device; Overheating of Device; Defective Component
IT WAS REPORTED THAT THE INSULATION WAS COMPROMISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14136488 ↗MalfunctionJun 8, 2021Melted; Material Deformation
IT WAS REPORTED THAT THE HEAT SHRINK AND SHEATH MELTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11958585 ↗MalfunctionJun 8, 2021Melted
IT WAS REPORTED THAT THE HEAT SHRINK AND SHEATH MELTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11958581 ↗InjuryDec 15, 2020Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem
IT WAS REPORTED THAT THE PATIENT WAS BURNED DURING PROCEDURE.
Patient problems: Burn(s); Burn, Thermal
MAUDE report 11008650 ↗MalfunctionSep 9, 2019Break
IT WAS REPORTED THAT THE DEVICE BROKE INSIDE THE PATIENT. AN X-RAY OF THE ABDOMEN CONFIRMED IT WAS NEGATIVE FOR FOREIGN BODY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8975470 ↗InjuryNov 27, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS BURNED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Burn(s)
MAUDE report 8107209 ↗MalfunctionSep 19, 2018Contamination /Decontamination Problem
IT WAS REPORTED THAT THE CAUTERY PROBE COMPROMISED THE OUTER SHEATH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7890714 ↗InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS A BURN TO THE PATIENT. PLEASE NOTE THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Burn, Thermal
MAUDE report 7754591 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K934094. One submission often covers many models, so check the product and lot details in each record.
- Z-2170-2025 · Jun 18, 2025 · Open, ClassifiedStryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
- Z-1509-2020 · Sep 12, 2019 · TerminatedStryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was distributed with the followin
- Z-0835-2018 · Nov 17, 2017 · TerminatedStrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION
Other Laparoscope, general & plastic surgery devices
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- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
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- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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