PDS D9424Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031033054), received between Aug 3, 2023 and Oct 6, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 16, 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.

• InjuryOct 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RESPIRATORY PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED AT THE INTERCOSTAL SPACE. IT WAS STATED THAT THIS CASE WAS A SURGERY IN WHICH A MALIGNANT LOBECTOMY WAS PLANNED BUT COULD NOT BE RESECTED AND THE CHEST WAS CLOSED. THE CHEST WAS OPENED POSTEROLATERALLY AND APPROACHED FROM THE BACK. POST-OP, 15 DAYS AFTER THE PROCEDURE, HEMOTHORAX OCCURRED DURING A PHYSICAL EXAMINATION AND WAS TREATED URGENTLY. A WOUND DEHISCENCE ALSO OCCURRED. WHEN THE CHEST WAS OPENED, TWO OF THE THREE SUTURE STITCHES HAD BEEN CUT. THEY WERE STITCHED WITH Z SUTURES. IT WAS OPINED THAT WHEN SUTURING THE INTERCOSTAL SPACE, THE VENOUS VESSELS WERE ALSO SUTURED TOGETHER, AND THE HEMOTHORAX MAY HAVE OCCURRED AT THE SAME TIME THE THREADS WERE BROKEN. HEMOTHORAX OCCURRED AND REOPENING CHEST PROCEDURE. THE PATIENT'S HOSPITAL STAY WAS PROLONGED BECAUSE OF THE WOUND INFECTION. THE PATIENT WAS HOSPITALIZED WITH CONCOMITANT SSI. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma; Unspecified Infection; Wound Dehiscence

  MAUDE report 17890129 ↗
• InjuryAug 3, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RESPIRATORY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED AT THE INTERCOSTAL SPACE. IT WAS STATED THAT THIS CASE WAS A SURGERY IN WHICH A MALIGNANT LOBECTOMY WAS PLANNED BUT COULD NOT BE RESECTED AND THE CHEST WAS CLOSED. THE CHEST WAS OPENED POSTEROLATERALLY AND APPROACHED FROM THE BACK. POST-OP, 15 DAYS AFTER THE PROCEDURE, HEMOTHORAX OCCURRED DURING A PHYSICAL EXAMINATION AND WAS TREATED URGENTLY. A WOUND DEHISCENCE ALSO OCCURRED. WHEN THE CHEST WAS OPENED, TWO OF THE THREE SUTURE STITCHES HAD BEEN CUT. THEY WERE STITCHED WITH Z SUTURES. IT WAS OPINED THAT WHEN SUTURING THE INTERCOSTAL SPACE, THE VENOUS VESSELS WERE ALSO SUTURED TOGETHER, AND THE HEMOTHORAX MAY HAVE OCCURRED AT THE SAME TIME THE THREADS WERE BROKEN. HEMOTHORAX OCCURRED AND REOPENING CHEST PROCEDURE. THE PATIENT'S HOSPITAL STAY WAS PROLONGED BECAUSE OF THE WOUND INFECTION. THE PATIENT WAS HOSPITALIZED WITH CONCOMITANT SSI. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma; Unspecified Infection; Wound Dehiscence

  MAUDE report 17455101 ↗