PI 4901TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521066519), received between Aug 29, 2018 and Jan 2, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCTECTOMY AND J POUCH, WHEN THE STAPLER WAS POSITIONED TO STAPLE THE RECTUM, THE BLACK BUTTON ON THE SIDE OF THE HANDLE FELL INTO THE PATIENT CAVITY. THE SURGEON EXPLORED THE PELVIS AND FOUND THE PIECE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8210869 ↗
• InjuryAug 29, 2018Fluid/Blood Leak; Failure to Form Staple; Fluid/Blood Leak; Failure to Form Staple

  ACCORDING TO THE REPORTER: DURING THE CLOSURE OF AN OPEN ESOPHAGECTOMY, THERE HAD BEEN A LEAKAGE. THE DEVICE HAS NOT BEEN STAPLED CORRECTLY. TO RESOLVE THE ISSUE, LAVAGE WAS PERFORMED, A STENT WAS INSERTED AT THE REVISION OPERATION, AND THE LEAKAGE WAS OVER SEWN. THE SURGICAL TIME WAS EXTENDED TO MORE THAN 30 MINUTES AND THE PATIENT HOSPITALIZATION WAS PROLONGED. AN ADDITIONAL OPERATION WAS ALSO PERFORMED.

  Patient problems: No Code Available

  MAUDE report 7829131 ↗
• InjuryAug 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, DURING AN OPEN LOW ANTERIOR RESECTION, ON CLOSURE OF THE RECTUM, THE INSTRUMENT COULD BE TRIGGERED CORRECTLY. THE ANASTOMOSIS WAS MADE WITH ANOTHER CIRCULAR STAPLER. THE DONUTS OF THE CIRCULAR STAPLER WERE COMPLETE. DURING THE LEAK TEST, A LEAKAGE WAS DETECTED. THE SURGEON OVERSTITCHED THE LEAKAGE TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 7826656 ↗