Digitex 52025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708932440127), received between Nov 28, 2017 and Dec 1, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE SEPARATED DURING USE. THE BULLET THAT THE NEEDLE LOCKS INTO WHEN THE HANDLE IS SQUEEZED INTO THE LIGAMENT WAS LOST FROM THE DEVICE. THE DEVICE WAS LOADED CORRECTLY WITH THE SUTURE AND THE DOCTOR USED IT IN THE PATIENT. THE DOCTOR REPORTED THE BULLET CAME OFF IN THE PATIENT AND HE WAS ABLE TO CONTINUE THE PROCEDURE AS IT IS SUPPOSED TO GO. THE DEVICE DID NOT BREAK OR PERFORM LIKE IT WAS SUPPOSED TO. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15894400 ↗
• InjuryMay 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT'S LEGAL REPRESENTATIVE STATED, THE PATIENT HAD ISSUES AFTER THE PROCEDURE DUE TO PAIN. THE PATIENT STATED AT A LATER TIME THAT SHE WAS IMPROVING. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT'S LEGAL REPRESENTATIVE STATED AT LEAST ONE OF THE STITCHES MADE BY THE PHYSICIAN, UNDER THE GUIDANCE OF ANOTHER PHYSICIAN, VIA THE DIGITEX DEVICE, WAS MADE THROUGH THE PUDENDAL NERVE, THE PUDENDAL NERVE BUNDLE AND/OR ONE OF IT'S BRANCHES, CAUSING THE PATIENT TO SUFFER PUDENDAL NEURALGIA, ALONG WITH OTHER ASSOCIATED SERVE NERVE PAIN.

  Patient problems: Pain

  MAUDE report 7535190 ↗
• InjuryNov 28, 2017Sticking

  ACCORDING TO THE AVAILABLE INFORMATION, DIGITEX NEEDLE AND CAP WERE STUCK TOGETHER IN THE SS LIGAMENT AFTER FIRING. FINALLY REMOVED WITH A HALSTEAD BY PULLING DOWN ON THE NEEDLE TO POP AND RELEASE. NEEDLE/CAP MAY HAVE FAILED. EXCESS TISSUE CAPTURED BETWEEN NEEDLE AND CAP MAY HAVE BEEN THE CAUSE. THE PROCEDURE WAS DELAYED 60 MINUTES, NO HARM TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7064983 ↗