LIGACLIP ER320Recalls & reported problems
Ethicon Endo-Surgery, LLC · LIGACLIP 10-M/L, 10mm Endoscopic Rotating Multiple Clip Appliers · Class 2 · Implant
All models of LIGACLIP (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon LigaClip endoscopic clip applier is used to place surgical clips. Most of its 1,091 reports describe clips not forming properly or the applier failing to fire, and some describe jams. The reports include no deaths and 39 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
- 1,115
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,115 adverse event reports that list this exact device (DI 10705036012580), received between Jan 22, 2014 and Sep 30, 2026 — classified as 39 injuries, 1,076 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (504 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. 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
- Failure to Form Staple504
- Failure to Fire247
- Difficult to Open or Close123
- Firing Problem65
- Mechanical Jam42
- Mechanical Problem37
- Insufficient Device Problem Information21
- Adverse Event Without Identified Device or Use Problem19
Patient problems
- No Clinical Signs, Symptoms or Conditions578
- No Consequences Or Impact To Patient494
- No Code Available18
- Failure to Anastomose15
- Hemorrhage/Blood Loss/Bleeding13
- Blood Loss6
- Unspecified Tissue Injury6
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 1,115 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Form Staple
It was reported the during a laparoscopic cholecystectomy that 5 clips from the ER320 did not properly close. The surgeon completed the procedure with an endoloop. It is unknown if the first clip was preloaded into the jaws of the clip applier.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946468 ↗MalfunctionSep 29, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935395 ↗MalfunctionSep 29, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935390 ↗MalfunctionSep 21, 2026Failure to Fire; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846292 ↗MalfunctionSep 21, 2026Failure to Fire; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846290 ↗MalfunctionSep 21, 2026Failure to Fire; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846289 ↗MalfunctionSep 21, 2026Difficult to Open or Close; Mechanics Altered
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846260 ↗MalfunctionSep 21, 2026Firing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843883 ↗MalfunctionSep 21, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843150 ↗MalfunctionSep 21, 2026Difficult to Open or Close
It was reported that during an Unknown procedure the clip fired and then jammed, device would not open.Was there any reported patient or user harm? No.Was there a significant delay? Unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840819 ↗MalfunctionSep 21, 2026Failure to Form Staple
It was reported that during an Unknown procedure the Ligaclip when firing the clips did not form. The product had to be replaced to complete the procedure. Was there any harm to the reported patient or user? No. Was there a significant delay? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840772 ↗MalfunctionSep 21, 2026Failure to Fire; Difficult to Open or Close; Mechanical Jam
It was reported that during an Unknown surgery, rotation Issue and then could not fire and could not open the jaw anymore. Changed the new one to complete surgery. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839285 ↗MalfunctionSep 16, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794468 ↗MalfunctionSep 16, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791368 ↗MalfunctionSep 16, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788464 ↗MalfunctionSep 16, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788406 ↗MalfunctionSep 16, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788144 ↗MalfunctionSep 15, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778658 ↗MalfunctionSep 15, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777897 ↗MalfunctionSep 15, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774389 ↗MalfunctionSep 14, 2026Failure to Fire
It was reported that during an unknown surgical procedure, the ER320 clip applicator, lot 583D61, presented a functional failure at the time of use, since it did not trigger any clip. The event was identified during the procedure and the product was withdrawn for evaluation. No harm to the patient was reported.Was there any harm to the reported patient or user? No.Was there a significant delay? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752459 ↗MalfunctionSep 14, 2026Failure to Form Staple
It was reported that during an Unknown procedure and during use, the clip did not close down completely (probable defect of the clip).Use of a second device for surgery.No clinical consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50751982 ↗MalfunctionSep 11, 2026Failure to Fire
It was reported that during an Unknown surgery, could not fire. Changed the new one to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733686 ↗MalfunctionSep 11, 2026Difficult to Open or Close
It was reported that during an unknown surgery, after fired, could not open the jaw. Opened the jaw manually with big force. There were no adverse consequences to the patient. No additional information could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733641 ↗MalfunctionSep 11, 2026Failure to Fire
It was reported that during a Laparoscopic cholecystectomy when loading the first clip, the trigger was locked, preventing the use of any clips on the device. Was there any harm to the reported patient or user? No. Was there a significant delay? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733460 ↗
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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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