Sofsilk GS-834Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521085268), received between Sep 7, 2018 and Sep 25, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).

13 other recalls cover devices cleared under the same FDA submission (K981128); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

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

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC WITH ABDOMINAL LAVAGE PROCEDURE, TWO SUTURES WERE USED, AND BOTH NEEDLES DETACHED WHILE BEING REMOVED FROM THE ABDOMEN THROUGH A TROCAR AND FELL INTO THE PATIENT'S CAVITY. THEY WERE RETRIEVED WITH A LAPAROSCOPIC GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304764 ↗
• MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC WITH ABDOMINAL LAVAGE PROCEDURE, TWO SUTURES WERE USED, AND BOTH NEEDLES DETACHED WHILE BEING REMOVED FROM THE ABDOMEN THROUGH A TROCAR AND FELL INTO THE PATIENT'S CAVITY. THEY WERE RETRIEVED WITH A LAPAROSCOPIC GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304761 ↗
• MalfunctionFeb 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA, THE STAPLER DID NOT FIRE AND THE NEEDLE OF THE SUTURE BROKE. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506510 ↗
• MalfunctionAug 18, 2021Break; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Break; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material

  ACCORDING TO THE REPORTER, DURING OPEN CAPSULECTOMY WITH IMPLANT, ON SUTURING, NEEDLE BROKE OFF. THE NEEDLE TIP FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED BY USING A MAGNET. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338017 ↗
• MalfunctionApr 8, 2020Break; Break

  ACCORDING TO THE REPORTER, ON A PROCEDURE, DURING THE CLOSURE OF THE SKIN, THE TIP OF THE NEEDLE BROKE WHILE SUTURING. THE TIP WAS RETRIEVED.

  Patient problems: No Information

  MAUDE report 9935986 ↗
• InjuryMar 30, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE SUTURING DURING TRACHEOSTOMY, THE TIP OF THE NEEDLE BROKE OFF ON THE NEEDLE DRIVER. THE NEEDLE AND THE BROKEN TIP WERE REMOVED FROM THE FIELD. THE SURGEON CONFIRMED THAT THE SURGICAL SITE WAS CLEAR, AND NOT RETAINED IN PATIENT.

  Patient problems: No Information

  MAUDE report 9896457 ↗
• MalfunctionJan 7, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT TWO HOURS IN THE PROCEDURE WHEN SUTURING THE STOMACH WITH INTERRUPTED LAPAROSCOPIC ROBOTIC SUTURE DURING A ROBOTIC LAPAROSCOPIC HIATAL HERNIA, THE SUTURE WAS HYDRATED PRIOR TO USE, BUT THREAD BROKE WHILE TYING KNOTS. THIS HAPPENED ON FOUR CONSECUTIVE SUTURES USED WITH NORMAL TENSION. SUTURE STRAND FELL INTO THE PATIENT'S CAVITY, AND WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. ANOTHER TECHNIQUE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9558161 ↗
• InjuryOct 12, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN TRYING TO BURY THE LEADS IN THE PECTORALIS MUSCLE DURING A DEVICE PLACEMENT OPEN PROCEDURE, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY WHILE PERFORMING SURGEON'S KNOT SUTURING TECHNIQUE. AN X-RAY WAS PERFORMED TO LOCATE THE COMPONENT OR TO CONFIRM THAT ALL PIECES WERE LOCATED. WITH IMAGING AND A FLUOROSCOPE, THE SURGICAL TEAM WAS ABLE TO RETRIEVE THE NEEDLE AND FINISHED THE CASE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9183045 ↗
• MalfunctionJul 10, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CARDIOVERTER DEFIBRILLATOR LEAD IMPLANT, THE NEEDLE BROKE OFF WHEN STARTING TO STITCH. IT WAS ALSO STATED THAT THE DEVICE FELL INTO THE PATIENT¿S CAVITY AND WAS REMOVED WITH AN INSTRUMENT. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775845 ↗
• MalfunctionSep 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE DRAPING ON THE PATIENT, THE NEEDLE DETACHED WHEN SKIN AND DRAPE WERE FIXED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7856077 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981128. One submission often covers many models, so check the product and lot details in each record.

• Z-1697-2024 · Jan 25, 2024 · Open, Classified
  Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation an
• Z-0845-2024 · Dec 21, 2023 · Open, Classified
  Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X
• Z-1176-2023 · Dec 2, 2022 · Open, Classified
  Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75C
• Z-2815-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 2/0 BLACK 5x18" V-20 D-TACH non-absorbable silk sutures GS62M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in
• Z-2816-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 3/0 18" BLACK V-20 DT non-absorbable braided nylon sutures GS63M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use
• Z-2817-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 2/0 30" BLACK V-20 DT non-absorbable braided nylon sutures GS66M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use
• Z-2814-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS46M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the c
• Z-2810-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 0 18" BLACK GS-21 DT non-absorbable braided nylon sutures CS10M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use i
• Z-2819-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 0 BLACK 6X 18" PRE-CUT WAX/RACE non-absorbable braided nylon sutures S196 Sofsilk is intended for use in general soft tissue approximation and/or ligation, inclu
• Z-2812-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 5/0 BLACK 5 X 18" CV-22 D*TACH non-absorbable silk sutures GS43M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use
• Z-2813-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS44M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the
• Z-2811-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 3/0 18" BLACK CV-25 DT non-absorbable silk sutures GS33M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the c
• Z-2818-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon sutures S194 Sofsilk is intended for use in general soft tissue approximation and/or ligation, includ