EXPRESSEW 214158Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705025206), received between Aug 3, 2018 and Feb 19, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 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.

• MalfunctionFeb 19, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THE SALES REP REPORTED VIA PHONE THAT HIS EXPRESSEW III AC LOADER/PLATE WAS TO THIN AND NOT STRONG ENOUGH TO HOLD THE SUTURES. THE SUTURE WAS NOT BEING HELD BY THE JAW DURING A ROTATOR CUFF REPAIR. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE CASE WAS COMPLETED WITH THE DEVICE. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8352357 ↗
• MalfunctionAug 3, 2018Material Twisted/Bent; Material Twisted/Bent

  THE SALES REPRESENTATIVE REPORTED THAT THE EXPRESSEW III AUTOCAPTURE LOADER PLATE WOULD NOT LOAD THE PLATE CORRECTLY. THE SALES REPRESENTATIVE REPORTED THAT WHEN THEY WOULD PULL BACK ON THE LOADER IT WOULD BEND THE PRONGS OF THE PLATE UP SLIGHTLY MAKING IT UNUSABLE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REPRESENTATIVE REPORTED THAT THE JAW OF THE CUSTOMER'S PENETRATING GRASPER WAS BENT UPWARD AND NO LONGER FLUSH CAUSING IT TO CATCH ON TISSUE. THE SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. ALL COMPLAINT DEVICES WERE DISCARDED. THE SALES REPRESENTATIVE WAS PRESENT AND CONFIRMED THE INSTRUCTIONS ON THE CARD WERE FOLLOWED. THE SALES REPRESENTATIVE CONFIRMED THAT THE PLATE DID NOT FALL OFF THE DEVICE AT ANY TIME. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52443.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7748031 ↗
• MalfunctionAug 3, 2018Material Twisted/Bent; Material Twisted/Bent

  THE SALES REPRESENTATIVE REPORTED THAT THE EXPRESSEW III AUTOCAPTURE LOADER PLATE WOULD NOT LOAD THE PLATE CORRECTLY. THE SALES REPRESENTATIVE REPORTED THAT WHEN THEY WOULD PULL BACK ON THE LOADER IT WOULD BEND THE PRONGS OF THE PLATE UP SLIGHTLY MAKING IT UNUSABLE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REPRESENTATIVE REPORTED THAT THE JAW OF THE CUSTOMER'S PENETRATING GRASPER WAS BENT UPWARD AND NO LONGER FLUSH CAUSING IT TO CATCH ON TISSUE. THE SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. ALL COMPLAINT DEVICES WERE DISCARDED. THE SALES REPRESENTATIVE WAS PRESENT AND CONFIRMED THE INSTRUCTIONS ON THE CARD WERE FOLLOWED. THE SALES REPRESENTATIVE CONFIRMED THAT THE PLATE DID NOT FALL OFF THE DEVICE AT ANY TIME. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52445.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7747977 ↗