Surgidac 170044Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20884521127019), received between Jan 8, 2019 and Aug 19, 2025 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE USING THE ENDOSTITCH INSTRUMENT, A NEEDLE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. THE SURGICAL TEAM WAS UNABLE TO LOCATE THE NEEDLE, SO IT WAS LEFT INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22841592 ↗
• InjuryJul 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ESOPHAGECTOMY, DURING ANASTOMOSIS, HALF OF THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT. THE SURGEON ORDERED AN X-RAY BUT WAS NOT ABLE TO FIND HALF OF THE NEEDLE. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19702585 ↗
• MalfunctionFeb 6, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE RELOAD'S PACKAGING WAS OPENED, IT WAS OBSERVED THAT ONE NEEDLE WAS MISSING. THE DEVICE WAS REMOVED FROM THE ROOM BEFORE THE PATIENT WAS ROLLED INTO THE ROOM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652305 ↗
• MalfunctionJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN UMBILICAL HERNIA REPAIR, THE SUTURE POPPED OFF THEN ANOTHER TWO MORE OF THE SAME LOT NUMBER AND THE SAME ISSUE WAS HAPPENED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051527 ↗
• MalfunctionApr 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS, AT ANASTOMOSIS, THE SUTURE POPPED OFF THE NEEDLE. TWO MORE RELOADS FROM THE SAME LOT WAS USED BUT SAME THING OCCURRED. ANOTHER RELOAD FROM DIFFERENT LOT WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690384 ↗
• MalfunctionDec 22, 2022Break; 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, ON A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS AND HIATAL HERNIA REPAIR, DURING THE CREATION OF SIDE-TO-SIDE ANASTOMOSIS, THE DEVICES HAD UNLOADING DIFFICULTIES. THREE NEEDLES BROKE, DISENGAGED FROM THE HANDLE, AND FELL INTO THE PATIENT¿S CAVITY. ALL THREE NEEDLES WERE RETRIEVED WITH A LAPAROSCOPIC GRASPER. A SINGLE-USE SUTURING DEVICE WAS USED INSTEAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040561 ↗
• MalfunctionDec 22, 2022Break; 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, ON A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS AND HIATAL HERNIA REPAIR, DURING THE CREATION OF SIDE-TO-SIDE ANASTOMOSIS, THE DEVICES HAD UNLOADING DIFFICULTIES. THREE NEEDLES BROKE, DISENGAGED FROM THE HANDLE, AND FELL INTO THE PATIENT¿S CAVITY. ALL THREE NEEDLES WERE RETRIEVED WITH A LAPAROSCOPIC GRASPER. A SINGLE-USE SUTURING DEVICE WAS USED INSTEAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040395 ↗
• MalfunctionDec 22, 2022Break; 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, ON A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS AND HIATAL HERNIA REPAIR, DURING THE CREATION OF SIDE-TO-SIDE ANASTOMOSIS, THE DEVICES HAD UNLOADING DIFFICULTIES. THREE NEEDLES BROKE, DISENGAGED FROM THE HANDLE, AND FELL INTO THE PATIENT¿S CAVITY. ALL THREE NEEDLES WERE RETRIEVED WITH A LAPAROSCOPIC GRASPER. A SINGLE-USE SUTURING DEVICE WAS USED INSTEAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040382 ↗
• MalfunctionJan 8, 2019Difficult to Open or Close; Human-Device Interface Problem; Difficult to Open or Close; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE WAS DIFFICULT TO TOGGLE AND JAWS WOULD NOT OPEN ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8228318 ↗

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