SURGICEL 3123SPEARecalls & reported problems
Ethicon, LLC · Endoscopic Applicator · Class 3
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031237513), received between Jun 8, 2022 and Aug 14, 2024 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (5 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
- Delivered as Unsterile Product5
- Adverse Event Without Identified Device or Use Problem1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND ABSORBABLE HEMOSTAT WAS USED. WHEN A NURSE OPENED THE PACKAGE, IT FOUND THAT THERE WAS A HAIR IN THE PACKAGE. PATIENT, DOCTORS, AND NURSES ALL WEAR CAPS, SO IT IS VERY LIKELY THAT THE HAIR WAS NOT FROM SOMEONE IN THE OPERATING ROOM. ANOTHER PRODUCT WAS USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19982386 ↗InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY PROCEDURE ON (B)(6) 2023 AND ABSORBABLE HEMOSTAT WAS USED. POST-OPERATIVELY THE PATIENT EXPERIENCED BLEEDING. IT WAS ADDRESSED VIA A BLOOD TRANSFUSION AND THE PATIENT IS DOING FINE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 16732210 ↗MalfunctionJun 8, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT BEFORE A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, UPON ARRIVAL THE ABSORBABLE HEMOSTAT APPLICATOR WAS NOTICED TO BE UNSEALED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14632101 ↗MalfunctionJun 8, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT BEFORE A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, UPON ARRIVAL THE ABSORBABLE HEMOSTAT APPLICATOR WAS NOTICED TO BE UNSEALED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14632057 ↗MalfunctionJun 8, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT BEFORE A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, UPON ARRIVAL THE ABSORBABLE HEMOSTAT APPLICATOR WAS NOTICED TO BE UNSEALED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14631938 ↗MalfunctionJun 8, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT BEFORE A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, UPON ARRIVAL THE ABSORBABLE HEMOSTAT APPLICATOR WAS NOTICED TO BE UNSEALED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14631925 ↗MalfunctionJun 8, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT BEFORE A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, UPON ARRIVAL THE ABSORBABLE HEMOSTAT APPLICATOR WAS NOTICED TO BE UNSEALED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14631887 ↗
Other Agent, absorbable hemostatic, non-collagen based devices
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- SURGICEL FIBRILLAR 1961Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 recall2 deaths120 reports
- SURGICEL FIBRILLAR 1963Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 recall44 reports
- SURGICEL 1953Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based56 reports
- SURGICEL 1952Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 death41 reports
- SURGICEL FIBRILLAR 1962Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based35 reports
- Veriset HP0510ECovidien LP · Agent, Absorbable Hemostatic, Non-Collagen Based1 death33 reports
- SURGICEL SNoW 2082Ethicon, LLC · Agent, absorbable hemostatic, non-collagen based24 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.