Surgidac 170040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20884521126999), received between Jun 26, 2017 and Mar 17, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K934738); 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.

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.

• InjuryMar 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE BECAME DETACHED FROM THE THREAD. THE NEEDLE WAS EMBEDDED IN THE PATIENT AND WAS UNABLE TO BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24624264 ↗
• InjuryMar 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR PROCEDURE, THE NEEDLE FELL INTO THE PATIENT'S CAVITY. THE SURGEON LEFT THE NEEDLE IN THE PATIENT AS RETRIEVING IT WOULD HAVE CAUSED MORE HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 18898891 ↗
• MalfunctionOct 3, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA REPAIR WITH TOUPET FUNDOPLICATION PROCEDURE, AT THE TIME OF SURGICAL CREATION OF THE TOUPET FUNDOPLICATION, THE NEEDLE OF THE SUTURE FELL INTO THE PATIENT'S CAVITY. THE SURGEON SCANNED OR SEARCHED THE ABDOMINAL CAVITY UNTIL IT WAS SUCCESSFULLY IDENTIFIED AND RETRIEVED THE NEEDLE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865362 ↗
• MalfunctionDec 5, 2019Detachment of Device or Device Component; Human-Device Interface Problem; Material Twisted/Bent; Detachment of Device or Device Component; Human-Device Interface Problem; Material Twisted/Bent

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED ON CLOSURE OF THE CRURA DURING LAPAROSCOPIC HIATAL HERNIA, THE NEEDLE BROKE OFF THE SUTURE, AND ANOTHER NEEDLE AND SUTURE SNAPPED OFF. IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO TOGGLE, AND ANOTHER DEVICE BENT THE NEEDLE INSIDE IT. HOWEVER, THE NEEDLE WAS RETRIEVED BY USING GRASPERS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 9416058 ↗
• InjuryOct 3, 2019Break; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA, THE NEEDLE BROKE IN HALF DURING WRAPPING THE CRUCIAL. THE NEEDLE FELL INTO THE PATIENT'S CAVITY AND AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE. IT WAS RETRIEVED USING A GRASPER. ANOTHER HANDLE AND NEEDLE WAS USED TO COMPLETE THE CASE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9153181 ↗
• MalfunctionOct 2, 2019Detachment of Device or Device Component; Human-Device Interface Problem; Material Twisted/Bent; Detachment of Device or Device Component; Human-Device Interface Problem; Material Twisted/Bent

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED ON CLOSURE OF THE CRURA DURING LAPAROSCOPIC HIATAL HERNIA, THE NEEDLE BROKE OFF THE SUTURE, AND ANOTHER NEEDLE AND SUTURE SNAPPED OFF. IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO TOGGLE, AND ANOTHER DEVICE BENT THE NEEDLE INSIDE IT. HOWEVER, THE NEEDLE WAS RETRIEVED BY USING GRASPERS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 9148243 ↗
• MalfunctionSep 17, 2019Break; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HIATAL HERNIA, ONE SUTURING DEVICE WOULD NOT TOGGLE BACK AND FORTH AND ONE NEEDLE BROKE IN HALF ON THE DEVICE. THE DOCTOR WAS PASSING THE NEEDLE THROUGH THE TISSUE AND IT JUST POPPED IN HALF. ABLE TO FIND THE HALF OF THE NEEDLE THAT BROKE OFF AND WAS RETRIEVED USING A GRASPER. THE OTHER HALF WAS STILL ON THE DEVICE. THE DOCTOR SAID THE TISSUE WAS NOT THICK AND THE SUTURING DEVICE WAS WORKING FINE, THE NEEDLE JUST BROKE IN HALF. UNABLE TO IDENTIFY WHICH OF THE TWO SUTURING INSTRUMENT AND NEEDLE RELOAD HAD BROKEN NEEDLE. NEW SUTURING DEVICE AND NEEDLE WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 9076069 ↗
• MalfunctionSep 17, 2019Break; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HIATAL HERNIA, ONE SUTURING DEVICE WOULD NOT TOGGLE BACK AND FORTH AND ONE NEEDLE BROKE IN HALF ON THE DEVICE. THE DOCTOR WAS PASSING THE NEEDLE THROUGH THE TISSUE AND IT JUST POPPED IN HALF. ABLE TO FIND THE HALF OF THE NEEDLE THAT BROKE OFF AND WAS RETRIEVED USING A GRASPER. THE OTHER HALF WAS STILL ON THE DEVICE. THE DOCTOR SAID THE TISSUE WAS NOT THICK AND THE SUTURING DEVICE WAS WORKING FINE, THE NEEDLE JUST BROKE IN HALF. UNABLE TO IDENTIFY WHICH OF THE TWO SUTURING INSTRUMENT AND NEEDLE RELOAD HAD BROKEN NEEDLE. NEW SUTURING DEVICE AND NEEDLE WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 9076034 ↗
• MalfunctionJun 26, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. THE NEEDLE DISENGAGED FROM THE DEVICE. ANOTHER NEEDLE WAS OPENED BUT THE SAME ISSUE OCCURRED. TO COMPLETE THE PROCEDURE, A THIRD LOADING UNIT WAS USED. NO HARM TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6667262 ↗
• MalfunctionJun 26, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. THE NEEDLE DISENGAGED FROM THE DEVICE. ANOTHER NEEDLE WAS OPENED BUT THE SAME ISSUE OCCURRED. TO COMPLETE THE PROCEDURE, A THIRD LOADING UNIT WAS USED. NO HARM TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6667220 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K934738. One submission often covers many models, so check the product and lot details in each record.

• Z-2281-2026 · Apr 15, 2026 · Open, Classified
  Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
• Z-2543-2017 · May 3, 2017 · Terminated
  Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU