Monosof GNJ-283Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521075375), received between Sep 11, 2018 and May 11, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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

1 other recall 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 18, 2026.

Recalls naming this device

1. Dec 2, 2022Class IIOpen, 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-1174-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

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.

• MalfunctionMay 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LOW ANTERIOR RESECTION, WHEN DEVICE WAS STABBED INTO THE BODY FROM OUTSIDE THE BODY, THE THREAD CAME OUT OF THE NEEDLE WHEN THE STRAIGHT NEEDLE WAS TRIED TO BE INSERTED INTO THE ABDOMINAL CAVITY IN ORDER TO LIFT THE PERITONEUM. THE DEVICE WAS REPLACED WITH A NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366033 ↗
• MalfunctionAug 31, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCTECTOMY, THE TWO SUTURES WERE NOT ABLE TO SLIDE SMOOTHLY, THE SUTURES FELT CAUGHT WHEN PENETRATING TISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10474395 ↗
• MalfunctionDec 30, 2019Break; Product Quality Problem; Difficult to Remove; Break; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE THREAD WAS TRANSPARENT. ALSO, THE THREAD BROKE EASILY WHILE IN USE. WHILE INSERTING WITH THE NEEDLE, RESISTANCE WAS STRONG. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530433 ↗
• MalfunctionNov 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO PARTIAL GASTRECTOMY, THE THREAD ON ONE SIDE OF THE DOUBLE-ARMED NEEDLE WAS FOUND TO BE DISENGAGED FROM THE NEEDLE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9330125 ↗
• MalfunctionSep 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE WAS PASSED THROUGH A FORCEPS AND WHEN THE NEEDLE WAS PULLED OUT, THE THREAD SLIPPED OFF FROM THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7865965 ↗

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