Monosof GN-283Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521075320), received between Mar 28, 2018 and Jul 9, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

2 other recalls cover devices cleared under the same FDA submission (K900531); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A SURGICAL PROCEDURE, THE SPIRAL NEEDLE OF A NON-ABSORBABLE NYLON SUTURE INTO MULTIPLE PIECES UNDER STRESS WHILE BEING USED FOR SUTURING, AFFECTING THE SURGICAL PROCESS.

  Patient problems: Insufficient Information

  MAUDE report 22462444 ↗
• MalfunctionMay 21, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  DUPLICATE OF (B)(4).

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Stenosis

  MAUDE report 22063101 ↗
• MalfunctionMay 16, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC RADICAL GASTRECTOMY PROCEDURE, WHILE ANASTOMOSING THE GASTROINTESTINAL TRACT, THREE CONSECUTIVE PURSE-STRING SUTURES WERE PASSED THROUGH THE TUBULAR STAPLER AND THE CONNECTION BETWEEN THE NEEDLE AND THREAD BROKE. A NEW PACKAGE OF SUTURE WAS UNPACKED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Stenosis

  MAUDE report 22037491 ↗
• MalfunctionMay 16, 2025Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC RADICAL GASTRECTOMY PROCEDURE, WHILE ANASTOMOSING THE GASTROINTESTINAL TRACT, THREE CONSECUTIVE PURSE-STRING SUTURES WERE PASSED THROUGH THE TUBULAR STAPLER AND THE CONNECTION BETWEEN THE NEEDLE AND THREAD BROKE. A NEW PACKAGE OF SUTURE WAS UNPACKED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22037463 ↗
• MalfunctionMay 16, 2025Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL GASTRECTOMY PROCEDURE, WHILE ANASTOMOSING THE GASTROINTESTINAL TRACT, THREE CONSECUTIVE PURSE-STRING SUTURES WERE PASSED THROUGH THE TUBULAR STAPLER AND THE CONNECTION BETWEEN THE NEEDLE AND THREAD BROKE. A NEW PACKAGE OF SUTURE WAS UNPACKED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22037298 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE SUTURE EXPERIENCED BREAKAGE, WITH BOTH NEEDLE AND THREAD BROKE DURING USE.

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

  MAUDE report 21283935 ↗
• MalfunctionAug 15, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL GASTRECTOMY, WHEN THE DEVICE WAS USED TO SUTURE THE ESOPHAGUS, AT THE TIME OF THE PURSE-STRING SUTURE TECHNIQUE, WHEN THE SUTURE WAS PULLED AND TIGHTENED, THE SUTURE WAS BROKEN. A NEW SUTURE WAS USED IMMEDIATELY, BUT IT WAS BROKEN AGAIN. IT WAS NOTED THAT ONE WAS BROKEN IN THE MIDDLE AND ONE WAS BROKEN AT THE TAIL. NEW SUTURES WERE PLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19996179 ↗
• MalfunctionAug 15, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AT THE TIME OF PURSE-STRING SUTURE TECHNIQUE, THE TWO SUTURES WERE BROKEN. NEW SUTURES WERE PLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19996163 ↗
• MalfunctionAug 23, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RADICAL RESECTION OF RECTAL CANCER, THE SUTURE BROKE ON THE OPERATING TABLE. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277954 ↗
• MalfunctionAug 10, 2022Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN SUTURE WAS UNPACKED, IT WAS SHOWN IN THE ATTACHED IMAGE THAT THE THREAD WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202935 ↗
• InjuryAug 5, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, WHEN THE 2-0 PURSE-STRING NEEDLE WAS USED FOR ANASTOMOSIS, THE 3 MM FRONT OF THE NEEDLE WAS BROKEN. THE NEEDLE WAS LEFT IN THE ABDOMINAL CAVITY. THE NEEDLE WAS SEARCHED IN MANY PLACES BY MANY PEOPLE AND WAS REPORTED TO THE HEAD NURSE. THE RADIOLOGY DEPARTMENT WAS CONTACTED FOR MANY TIMES AND THE BROKEN NEEDLE WAS NOT FOUND IN THE ABDOMINAL CAVITY AND THORACIC CAVITY. THE ABDOMEN WAS CLOSED AS ORDERED BY THE DOCTOR. THE X-RAY FILM WAS KEPT, AND THE SURGEON INFORMED THE FAMILY OF THE EVENT.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 15179383 ↗
• MalfunctionMay 4, 2020Break; Break

  ACCORDING TO THE REPORTER, WHILE USING A GASTROINTESTINAL PURSE STRING SUTURE DURING A GASTROINTESTINAL SURGERY, THE SUTURE BROKE. THE DOCTOR REPEATEDLY CHANGED THE SUTURE AND USED IT, BUT THE SUTURE STILL BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020619 ↗
• MalfunctionApr 22, 2020Break; Break

  ACCORDING TO THE REPORTER, WHILE APPLYING A PURSE STRING SUTURE DURING AN OPEN ESOPHAGEAL PROCEDURE, THE THREAD BROKE OFF WHEN BEING KNOTTED. THE PRODUCT WAS REPLACED TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 9988541 ↗
• MalfunctionMar 28, 2018Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE NURSE OPENED THE PACKAGE, THE PRODUCT WAS DISCOLORED AND THE THREAD BROKE EASILY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7379583 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900531. One submission often covers many models, so check the product and lot details in each record.

• Z-1173-2023 · Dec 2, 2022 · Open, Classified
  Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX
• Z-1174-2023 · Dec 2, 2022 · Open, Classified
  Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 10