Endopath PN120Recalls & reported problems
Ethicon Endo-Surgery, LLC · Endopath Pneumoneedle Insufflation Needles with Luer Lock Connectors 120mm · Class 2
Quick summary
This Ethicon Endopath PN120 is a pneumoperitoneum (Veress) insufflation needle used to access the abdominal cavity for minimally invasive surgery. Most reports describe the spring-loaded inner mechanism failing to spring back or sticking when the needle is activated, and a few mention units arriving already opened or non-sterile, with some bleeding and unspecified tissue injury noted. There are 37 reports, including 1 death and 4 injuries. No recalls name 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
- 36
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10705036012962), received between Dec 17, 2019 and Jul 1, 2026 — classified as 1 death, 4 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available26
- Insufficient Device Problem Information4
- Patient Device Interaction Problem4
- Delivered as Unsterile Product3
- Improper Flow or Infusion2
- Mechanical Jam1
- Retraction Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Hemorrhage/Blood Loss/Bleeding3
- No Consequences Or Impact To Patient2
- Unspecified Tissue Injury2
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT PRIOR TO A ROBOTIC GALLBLADDER PROCEDURE, THE NEEDLE WAS TESTED BEFORE THE CASE DUE TO PREVIOUS ISSUES. DURING TESTING, THE NEEDLE DID NOT SPRING BACK AND APPEARED TO STICK TO THE PLASTIC, BECOMING STUCK. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683410 ↗MalfunctionMay 23, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING A DA VINCI NEPHRECTOMY SURGERY, AFTER ANESTHESIA, WAS PREPARING TO ESTABLISH AN AIRPLANE, AND WHEN USING THE PN120 PNEUMOPERITONEUM NEEDLE, FOUND THAT THE PRODUCT'S INNER SPRING COULD NOT REBOUND BACK CORRECTLY. AFTER REPLACING A NEW ONE, IT IS NORMAL, AND THE PATIENT IS NOT AFFECTED IN ANY WAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264684 ↗MalfunctionMay 22, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, SPRING MECHANISM ON THE TOP OF THE 120MM VERRIS INSUFFLATION NEEDLE WAS NOT SPRINGING BACK. OPENED A SECOND ONE OF A DIFFERENT LOT NUMBER, SAME ISSUE. SWITCHED TO 150MM VERRIS TO CONTINUE CASE. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256039 ↗MalfunctionMar 4, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, HAD ISSUES WITH THE SPRING IN IT. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506815 ↗MalfunctionOct 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SPRING OF THE VERESS NEEDLE FAILED TO RETRACT. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23346523 ↗MalfunctionSep 8, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN CHECKING THE BOX, AN OPEN PIECE IS FOUND WITHOUT BEING ABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22990860 ↗MalfunctionJul 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING A HERNIA REPAIR THE NURSE INSTRUMENTALIST CHECKS THE NEEDLE BEFORE STARTING THE PROCEDURE AND REALIZES THAT WHEN IT IS ACTIVATED IT DOES NOT RETURN. THE DOCTOR REVIEWS IT AND GIVES THE SAME VERDICT. BY NOT RETURNING THE NEEDLE TO THE ORIGINAL POSITION ALONE, IT WOULD NOT WORK TO DETERMINE IF THE DOCTOR ENTERS THE CAVITY CORRECTLY. ANOTHER IS THEREFORE REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22411260 ↗MalfunctionApr 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE INSUFFLATION NEEDLE FAILED TO RETRACT. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21893185 ↗MalfunctionApr 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SPRING IS NOT FUNCTIONALLY PROPERLY. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751021 ↗MalfunctionApr 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SPRING IS NOT FUNCTIONALLY PROPERLY. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751020 ↗MalfunctionApr 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SPRING IS NOT FUNCTIONALLY PROPERLY. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751018 ↗MalfunctionMar 25, 2025Improper Flow or Infusion; Appropriate Device Problem Term/Code Not Available; Improper Flow or Infusion; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NEEDLE IS BLOCKED AND THE SAFETY SYSTEM IS FAULTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21687573 ↗MalfunctionNov 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLE WAS HAVING TROUBLE SPRINGING BACK UP CORRECTLY AND WAS GETTING STUCK. HAD TO GET A NEW ONE. NO PATIENT CONSEQUENCE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20775252 ↗MalfunctionOct 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SPRING CANNOT REBOUND. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20525212 ↗MalfunctionOct 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SPRING CANNOT BOUNCE BACK. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20515807 ↗MalfunctionOct 22, 2024Improper Flow or Infusion; Appropriate Device Problem Term/Code Not Available; Improper Flow or Infusion; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PNEUMONEEDLE WAS INSERTED INTO THE INCISION SITE, BUT THE SPRING DID NOT WORK AS INTENDED TO GIVE PHYSICAL FEEDBACK OF ABDOMINAL LAYERS. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20508005 ↗MalfunctionOct 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SAFETY NEEDLE REMAINED EXPOSED AFTER PUNCTURE AND DID NOT RETRACT. OPENED A NEW PRODUCT TO COMPLETE CASE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20351295 ↗MalfunctionOct 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SAFETY NEEDLE REMAINED EXPOSED AFTER PUNCTURE AND DID NOT RETRACT. OPENED A NEW PRODUCT TO COMPLETE CASE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20351291 ↗MalfunctionOct 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN ROBOTIC PROCEDURE, THE SAFETY NEEDLE REMAINED EXPOSED AFTER PUNCTURE AND DID NOT RETRACT. OPENED A SECOND PRODUCT TO COMPLETE CASE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20351135 ↗MalfunctionOct 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING A ROBOTIC NEPHRECTOMY, THE SAFETY NEEDLE REMAINED EXPOSED AFTER PUNCTURE AND DID NOT RETRACT. OPENED A NEW PRODUCT TO COMPLETE CASE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350998 ↗MalfunctionOct 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING A ROBOTIC NEPHRECTOMY, THE SAFETY NEEDLE REMAINED EXPOSED AFTER PUNCTURE AND DID NOT RETRACT. OPENED A NEW PRODUCT TO COMPLETE CASE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350993 ↗MalfunctionAug 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SPRING IS STUCK AND CANNOT REBOUND. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20034324 ↗MalfunctionJul 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SPRING CANNOT BOUNCE BACK. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19757038 ↗MalfunctionJun 11, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT PRE PROCEDURE, IT WAS NOTICED THAT THERE WAS A HOLE IN THE BAG, RENDERING IT NONSTERILE. CASE COMPLETED WITH LIKE DEVICE. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19512849 ↗MalfunctionMar 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SPRING COULD NOT REBOUND. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18932062 ↗
Other APPARATUS, PNEUMOPERITONEUM, AUTOMATIC devices
- Endopath PN150Ethicon Endo-Surgery, LLC · APPARATUS, PNEUMOPERITONEUM, AUTOMATIC14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.