Surgipro CP-535Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521036512), received between Feb 12, 2019 and Jul 25, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 2, 2022Open, Classified

   Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

   Z-1179-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE DETACHED FROM THE THREAD.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19831035 ↗
• MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN UMBILICAL HERNIA REPAIR, WHEN MOUNTING THE SUTURE ONTO THE NEEDLE HOLDER, TWO SUTURES DETACHED FROM THE NEEDLE. ANOTHER SUTURE HAD THE SAME ISSUE WHEN THE SURGEON WAS SUTURING TO REPAIR THE UMBILICAL HERNIA. A DIFFERENT SUTURE ALTOGETHER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625827 ↗
• MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN UMBILICAL HERNIA REPAIR, WHEN MOUNTING THE SUTURE ONTO THE NEEDLE HOLDER, TWO SUTURES DETACHED FROM THE NEEDLE. ANOTHER SUTURE HAD THE SAME ISSUE WHEN THE SURGEON WAS SUTURING TO REPAIR THE UMBILICAL HERNIA. A DIFFERENT SUTURE ALTOGETHER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625805 ↗
• MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN UMBILICAL HERNIA REPAIR, WHEN MOUNTING THE SUTURE ONTO THE NEEDLE HOLDER, TWO SUTURES DETACHED FROM THE NEEDLE. ANOTHER SUTURE HAD THE SAME ISSUE WHEN THE SURGEON WAS SUTURING TO REPAIR THE UMBILICAL HERNIA. A DIFFERENT SUTURE ALTOGETHER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625777 ↗
• MalfunctionFeb 10, 2023Detachment of Device or Device Component; Manufacturing, Packaging or Shipping Problem; Detachment of Device or Device Component; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, TWO SEPARATE NEEDLES AND THREAD WERE FOUND IN THE SAME SUTURE PACKET. TO RESOLVE THE ISSUE, USED THREE ADDITIONAL SUTURES FROM THE SAME LOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16350161 ↗
• MalfunctionApr 6, 2021Break; Dull, Blunt; Break; Dull, Blunt

  ACCORDING TO THE REPORTER, DURING CLOSURE OF AN OPEN PROSTATECTOMY, WHILE USING A KNOT TYING TECHNIQUE, IT WAS NOTED THAT THE NEEDLE WAS BLUNT AND BROKEN. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624763 ↗
• MalfunctionFeb 12, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA SURGERY, THE FIRST SUTURE BROKE WHILE SEWING AND THE SECOND SUTURE BROKE WHILE TYING THE KNOT. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331527 ↗