Surgidac 170043Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20884521128979), received between May 8, 2017 and Jul 14, 2021 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HIATAL HERNIA PROCEDURE, THE NEEDLE FELL OFF INTO THE PATIENT CAVITY. THE SURGEON LOOKED FOR THE NEEDLE BUT IT COULD NOT BE FOUND AND REMAINED IN THE PATIENT'S DIAPHRAGM. THEY TRIED GETTING IT OUT WITH THE NEEDLE DIVERS BUT THE NEEDLE WAS CAUSING DAMAGE TO THE CRURAL MUSCLES SINCE IT WAS DEEPLY BURIED INSIDE THE LEFT CRUS MUSCLE. A NEW SUTURE LOADING UNIT WAS OPENED TO COMPLETE THE CASE. ADDITIONALLY, IT WAS STATED THAT THE PATIENT WAS INFORMED THAT THE NEEDLE AS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12166272 ↗
• InjuryJan 27, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN SUTURING, HALF OF THE NEEDLE BROKE OFF. THE NEEDLE FELL OFF INTO THE PATIENT'S CAVITY. IT WAS REPORTED THAT THEY USED X-RAY IN CHECKING ALL PARTS, BUT THEN THEY WERE UNABLE TO FIND IT.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 9635236 ↗
• MalfunctionMay 22, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA PROCEDURE, THE NEEDLE BROKE IN HALF AND IT WAS RETRIEVED IN THE PATIENT AFTER SEARCHING FOR IT. IT WAS REPORTED THAT LAPAROSCOPIC SUTURING WAS ALREADY COMPLETE BY THE TIME IT WAS NOTICED THAT THE NEEDLE BROKE IN HALF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8632925 ↗
• MalfunctionMar 16, 2019Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem; Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A BYPASS PROCEDURE, THE DEVICE WAS JAMMING AND NOT LOCKING IN THE NEEDLE. THE NEEDLE FELL OUT INTO THE PATIENT'S CAVITY AND WAS RETRIEVED USING GRASPER. NEEDLE RELOADS WERE NOT LOADED ON THE DEVICE AS WELL. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE.THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426577 ↗
• MalfunctionNov 29, 2018Break; Component or Accessory Incompatibility; Detachment of Device or Device Component; Break; Component or Accessory Incompatibility; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE, WHILE LOADING THE DEVICE, THE NEEDLE BROKE OFF FROM THE INSTRUMENT TIP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8115894 ↗
• MalfunctionNov 13, 2018Break; Break

  ACCORDING TO THE REPORTER, WHILE THE SRUB TECH WAS LOADING THE DEVICE DURING A PROCEDURE, THE NEEDLE BROKE. THEY OPENED A NEW DEVICE TO COMPLETE THE PROCEDURE. THE EVENT HAPPENED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED TO THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8064383 ↗
• InjuryJul 11, 2018Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE SUTURING IN A LAPAROSCOPIC EXPLORATORY LAPAROTOMY WITH HERNIA REPAIR, THE NEEDLE FELL ON THE PATIENT¿S CAVITY AND WAS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7679583 ↗
• MalfunctionJun 20, 2018Detachment Of Device Component; Human-Device Interface Problem; Detachment Of Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO TOGGLE, LOAD AND UNLOAD. THE DEVICE WAS HARD TO OPERATE. TWO DIFFERENT NEEDLES FELL OUT OF THE JAW WHEN IT WAS PROPERLY LOADED AND IN THE LOCKED POSITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7620379 ↗
• MalfunctionFeb 13, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC NISSEN PROCEDURE, THE DEVICE¿S NEEDLE POPPED OUT OF JAWS WHILE BEING USED IN WRAP. SURGEON WAS MIDWAY THROUGH SUTURING AND COMPLETED TIE WITH GRASPERS. THE NEEDLE FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED BY GRASPERS. NEW DEVICE WAS USED SUCCESSFULLY WITH TWO SUBSEQUENT LOADS WITHOUT ISSUE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7267351 ↗
• InjuryNov 14, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER ,OCCURRED DURING A LAPAROSCOPIC THORACOTOMY PROCEDURE. THE SUTURING DEVICE WAS BEING APPLIED TO THE CHEST. THE NEEDLE BROKE INTO TWO PIECES AND FELL INTO THE CAVITY OF THE PATIENT. AN X-RAY WAS PERFORMED THAT DAY. THE OTHER HALF COULD NOT BE FOUND. THERE WAS NO ADDITIONAL PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: Foreign Body In Patient; Radiation Exposure, Unintended

  MAUDE report 7029305 ↗
• MalfunctionMay 8, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY. THE NEEDLE DISENGAGED FROM THE DEVICE AND FELL INTO THE CAVITY OF THE PATIENT. THE NEEDLE BROKE IN HALF. SURGEON BELIEVE THE NEEDLE WAS SUCKED UP WHEN THEY SUCTIONED. NO KNOWN PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6551017 ↗

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