Premium Polysorb 013501LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521047570), received between May 4, 2021 and May 4, 2021 — classified as 1 injury.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A STUDY PROSPECTIVELY ANALYZED 150 PATIENTS WHO UNDERWENT DISTAL PANCREATECTOMY IN THE LAST 20 YEARS. AN AUTO SUTURE STAPLER WAS USED TO LIGATE THE SPLENIC ARTERY AND VEIN IN PATIENTS WHO UNDERWENT SPLENECTOMY. THE DEVICE WAS USED TO AMPUTATE THE PANCREAS AND TWO STAPLES WERE LEFT IN THE PROXIMAL PANCREATIC STUMP. THE AVERAGE DURATION OF THE OPERATION WAS 150 MIN (RANGE: 90-210 MIN) AND NO TRANSFUSION WAS INDICATED DURING THE OPERATION. IF BLEEDING WAS OBSERVED, ANOTHER MANUFACTURE¿S SUTURE WAS USED TO OVERSEW THE AREA OF BLEEDING. NOTED MORBIDITY ON 5 PATIENTS, BUT NO MORTALITY OCCURRED IN THE POSTOPERATIVE PERIOD. OVERALL, THE POSTOPERATIVE PERIOD WAS UNEVENTFUL WITHOUT ANY COMPLICATIONS (PANCREATIC FISTULA, ABSCESS, BLEEDING OR WOUND INFECTION) IN 145 PATIENTS. IT WAS STATED THAT ONE POST-OPERATIVE PANCREATIC FISTULA WHICH WAS TREATED WITH MEDICATION AND JEJUNAL FEEDING. TWO PATIENTS SUFFERED PANCREATITIS AND REOPERATION DUE TO BLEEDING. REOPERATIONS WERE PERFORMED ON TWO PATIENTS ON THE FIRST OR SECOND POSTOPERATIVE DAY, NECESSITATED BY BLEEDING FROM THE RETROPERITONEAL REGION. HOSPITALIZATION WAS EXTENDED FOR PATIENTS WITH POST-OPERATIVE COMPLICATI

  Patient problems: Abscess; Fistula; Hemorrhage/Blood Loss/Bleeding; Post Operative Wound Infection

  MAUDE report 11769832 ↗