Poly Surgiclip 133649Recalls & reported problems
Covidien LP · Clip Applier with Polysorb Clips · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521133679), received between Nov 20, 2017 and Dec 3, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (2 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.
Most reported problems
Device problems
- Mechanics Altered2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2018Mechanics Altered; Mechanics Altered
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE EXPERIENCED ISSUE WITH THE LOADING/FIRING OF THE CLIPS. A SECOND PRODUCT HAD TO BE OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8127314 ↗MalfunctionNov 20, 2017Mechanics Altered; Mechanics Altered
ACCORDING TO THE REPORTER, DURING A COLORECTAL PROCEDURE, THE DEVICE HAD ISSUES WITH THE LOADING OR FIRING OF THE CLIPS. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7046143 ↗
Other CLIP, IMPLANTABLE devices
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- Endo Clip III 176630Covidien LP · CLIP, IMPLANTABLE1 death1,959 reports
- Epix® Universal Clip Applier CA500Applied Medical Resources Corporation · Clip, Implantable1 recall1 death1,183 reports
- Endo Clip II 176657Covidien LP · CLIP, IMPLANTABLE1,183 reports
- LIGACLIP ER320Ethicon Endo-Surgery, LLC · CLIP, IMPLANTABLE1,115 reports
- Direct Drive® Clip Applier CA090Applied Medical Resources Corporation · Clip, Implantable1 death806 reports
- LAPRA-TY XC200Ethicon Inc. · CLIP, IMPLANTABLE791 reports
- Endo Clip 176625Covidien LP · CLIP, IMPLANTABLE1 death768 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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