SURGICEL NU-KNIT 1941Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031002968), received between Aug 9, 2019 and Dec 29, 2023 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT, A 54 YEAR OLD MALE, WITH A HISTORY OF TREATMENT FOR PULMONARY TUBERCULOSIS. THORACIC PAIN EXAMINATION REVEALED THIRD-DEGREE RIGHT PNEUMOTHORAX ON CHEST X-RAY, AND CHEST TUBE DRAINAGE WAS PERFORMED. PREOPERATIVE CT SHOWED ATELECTASIS IN THE RIGHT UPPER LOBE DUE TO SEQUELAE OF PULMONARY TUBERCULOSIS, AND NUMEROUS BULLAE WERE PRESENT. DURING THE SURGERY, ADHESIONS WERE REMOVED AS MUCH AS POSSIBLE, AND A LEAK WAS FOUND FROM THE BULLA BETWEEN THE UPPER AND LOWER LOBES. THE BULLA WAS OPENED, AND A DIAGNOSIS WAS MADE THAT THE BULLA WAS BASED ON THE UPPER LOBE, AND IT WAS DECIDED TO SUTURE IT BECAUSE OF THE ADHESIONS AND PROXIMITY TO THE CENTRAL SIDE. FREE MEDIASTINAL FAT WAS FILLED INTO THE INCISED BULLA, AND THE FAT WAS USED AS A PLEDGET AND SUTURED WITH A 4-0 SUTURE. PLEURAL COVERING WAS PERFORMED USING OXIDIZED CELLULOSE DUE TO SEVERE EMPHYSEMATOUS CHANGES THROUGHOUT THE PATIENT. THE POSTOPERATIVE COURSE WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED ON THE 8TH POSTOPERATIVE DAY, BUT RECURRENCE WAS OBSERVED ON THE 15TH POSTOPERATIVE DAY, AND A SECOND SURGERY W

  Patient problems: Adhesion(s); Fluid Discharge; Pneumothorax

  MAUDE report 18418337 ↗
• InjuryAug 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY ON (B)(6) 2019 AND AN ABSORBABLE HEMOSTAT WAS USED. AN INFECTION OCCURRED. THE ABSORBABLE HEMOSTAT WAS LEFT IN THE ABDOMINAL CAVITY AS IT WAS FOR HEMOSTASIS DURING WOUND CLOSURE BECAUSE THE DEVICE WOULD BE ABSORBED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 8877309 ↗