Surgipro VP-977Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521039759), received between Dec 15, 2017 and Jun 5, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K954808); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2019Break; Break

  ACCORDING TO THE REPORTER, ON A ROBOTIC LAPAROSCOPIC PROCEDURE, THE THREAD BROKE. THE SUTURE WAS CUT IN HALF AND USED AS TWO SEPARATE SUTURES. BOTH SUTURES BROKE WHEN TYING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 8671755 ↗
• MalfunctionApr 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE, WHILE UNPACKING, THE SUTURE WAS DETACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8511691 ↗
• MalfunctionDec 19, 2017Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, FOUR DEVICES WERE USED AND THE DEVICE¿S NEEDLE AND THREAD BROKE. THE THREAD WAS UNABLE TO BE REMOVED FROM THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7130318 ↗
• MalfunctionDec 18, 2017Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE AND THREAD BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7127190 ↗
• InjuryDec 15, 2017Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  ACCORDING TO THE REPORTER, THE SUTURE WAS STUCK IN THE PACKAGE AND UNABLE TO BE REMOVED. THE HEALTHCARE PROFESSIONAL PUNCTURED HIS/HER FINGER DUE TO THE DEVICE PROBLEM. THE NURSE HAD JUST COMPLETED A PROCEDURE FOR A (B)(6) PATIENT, SO THE NURSE WAS AT RISK OF BEING INFECTED WITH (B)(6). THE HOSPITAL HAS STOPPED USING ALL SUTURES. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: Needle Stick/Puncture; No Consequences Or Impact To Patient

  MAUDE report 7123201 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954808. One submission often covers many models, so check the product and lot details in each record.

• Z-1179-2023 · Dec 2, 2022 · Open, Classified
  Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP