WECK IPN914988Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 24026704697100), received between Oct 19, 2021 and May 1, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED " THE CLIP APPLICATOR DOES NOT GRIP THE CLIPS, THE CLIPS FALL OUT OF THE CLIP APPLICATOR WHEN PUT ON BY THE SCRUB NURSE". NO PATIENT HARM OR INJURY REPORTED. IT IS ADDITIONALLY STATED " THE PATIENT DID NOT SUFFER ANY INJURIES DURING THE PROCEDURE".

  Patient problems: Insufficient Information

  MAUDE report 19226119 ↗
• MalfunctionOct 19, 2021Break; Failure to Align; Break; Failure to Align

  PLEASE NOTE THAT THE APPLIER TIP IS LOOSE NOT FIXED WITH THE SHAFT, SO WHEN YOU PRESS THE HANDLE THE JAWS MOVE FORWARD THEN GENERATE PRESSURE TO THE CLIP, WHICH CAUSE INCONVENIENCE WHILE USING AND THE JAWS ARE MISALIGNED. IT IS REPORTED THAT: DURING SURGERY IT STARTED TO LOOSEN THE TIP FROM SHAFT WHICH MAKES IT DIFFICULT AND INCONVENIENT TO WORK WITH. REGARDING THE STERILIZATION KINDLY NOTE THAT THE PRODUCT IS USUALLY STERILIZED AROUND 3 TIMES A DAY WITH CHEMICAL STERILIZATION (COLD STERILIZATION) STERILIZATION RECORD CARD IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656039 ↗