Quick Connect Assembly Tool 72400271Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878953000831), received between Nov 10, 2020 and Nov 10, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 10, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ARTIFICIAL URINARY SPHINCTER(AUS) IMPLANT SURGERY, THE PHYSICIAN RECEIVED A CONNECTOR ASSEMBLY TOOL WITH NO RED LABEL INDICATING THAT THE INSTRUMENT HAD BEEN STERILIZED. THE CUSTOMER THOUGHT THAT THERE WAS NO INFORMATION ON THE PACKAGE OF THE CONNECTOR TOOL STATING THAT THIS INSTRUMENT WAS NOT STERILE, BUT THERE WAS INFORMATION ON THE PACKAGING THAT INDICATED THAT THE CONNECTOR ASSEMBLE TOOL WAS NOT STERILIZED. BECAUSE OF THAT, THE PHYSICIAN DID NOT STERILIZE THE CONNECTOR ASSEMBLY TOOL AND THE SURGERY HAD TO BE POSTPONED. IT WAS NOTED THAT THE PACKAGING HAD NOT BEEN DAMAGED. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10816496 ↗