Poly GIA 030775Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521047679), received between Oct 31, 2017 and Jun 1, 2020 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A CYSTECTOMY ON THE IIEAL CONDUIT, THE DEVICE WAS PASSED TO THE DOCTOR AND IT WAS ATTEMPTED FOR FIRING, THE LEVER WAS HARD AND THE FIRING WAS UNABLE TO BE PERFORMED. THOUGH IT WAS RESET AGAIN BY THE NURSE, THE SITUATION WAS NOT IMPROVED, HENCE A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10104027 ↗
• MalfunctionMay 13, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING FIRING IN A LAPAROSCOPIC GYNECOLOGY PROCEDURE, THE DEVICE PARTIALLY FIRED. THEY CHANGE THE DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8603534 ↗
• InjuryApr 18, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN PRIMARY C/S REMOVAL OF PLACENTA PROCEDURE, WHILE TRYING TO REPAIR UTERINE WALL, THE TWO STAPLER COULD NOT BE FIRED. IT WAS NOTED THAT THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED AND THE STAPLES DID NOT DEPLOY. UTERINE WALL WAS REPAIRED WITH SUTURE.

  Patient problems: No Code Available

  MAUDE report 8528272 ↗
• MalfunctionMar 7, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER: DURING CYSTECTOMY/ILEAL CONDUIT, THE SURGEON CLAMPED THE TISSUE OF SMALL INTESTINE AND TRIED TO PUSH THE FIRING KNOB, HOWEVER IT WAS STIFF AND COULD NOT FIRE THE DEVICE AT ALL. REPLACED BY A NEW DEVICE, THE PROCEDURE WAS COMPLETED. NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7320076 ↗
• MalfunctionMar 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT WAS RETURNED WITHOUT A REPORTED ISSUE. EXAMINATION OF THE RETURNED SAMPLE FOUND A DISENGAGED CARTRIDGE AND A BROKEN FASTENER.

  Patient problems: No Information

  MAUDE report 7316615 ↗
• MalfunctionNov 15, 2017Physical Resistance; Failure to Fire; Human-Device Interface Problem; Physical Resistance; Failure to Fire; Human-Device Interface Problem

  THE CUSTOMER REPORTED THAT A DEVICE ISSUE OCCURRED DURING A CYSTECTOMY / ILEAL CONDUIT PROCEDURE. AFTER OPENING THE PACKAGING AND SETTING UP THE DEVICE, THE SETTING WAS NOT SMOOTH AND THE HANDLE WAS STIFF. THE SURGEON TRIED TO FIRE THE DEVICE, BUT IT DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036234 ↗
• MalfunctionOct 31, 2017Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER: DURING A CYSTECTOMY PROCEDURE WHEN THE SURGEON GRIPPED THE TISSUE AND TRIED TO STAPLE, THE FIRING KNOB DID NOT MOVE AT ALL AND COULD NOT STAPLE. TO COMPLETE THE PROCEDURE, ANOTHER DEVICE WAS USED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6991044 ↗