Surgidac 173024Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10884521129450), received between Feb 8, 2017 and Oct 23, 2025 — classified as 27 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Break” (41 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 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ESOPHAGECTOMY, TOWARDS THE END OF THE PROCEDURE, THE RESIDENT ASSISTING WITH THE DEVICE PLACED THE NEEDLE THROUGH NORMAL TISSUE, AND AFTER PULLING THE NEEDLE THROUGH THE OTHER END, THE DEVICE WAS NOT FULLY CLOSED. THE RESIDENT THEN PULLED THE DEVICE TO EXTEND THE SUTURE WHILE IT WAS OPEN, RESULTING IN THE NEEDLE BREAKING IN HALF. THE BROKEN NEEDLE FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED WITH A GRASPER. THE STAFF REMOVED THE NEEDLE AND SUTURING DEVICE FROM THE STERILE FIELD AND OPENED A NEW NEEDLE AND SUTURING DEVICE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367426 ↗
• MalfunctionJul 18, 2025Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR, WHILE SUTURING AND TYING THE KNOTS WITH THE ENDOSTITCH SUTURE, IT WAS FRAYING, AND THE SUTURE POPPED OFF THE NEEDLE WITH HARDLY ANY PRESSURE OR FORCE. THE SAME ISSUE OCCURRED ON A TOTAL OF 12 SUTURES FROM THE SAME BATCH AND ONE SUTURE FROM A DIFFERENT BATCH NUMBER. THE SURGEON OPENED MORE SUTURES FROM A DIFFERENT BATCH NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542076 ↗
• MalfunctionJul 18, 2025Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR, WHILE SUTURING AND TYING THE KNOTS WITH THE ENDOSTITCH SUTURE, IT WAS FRAYING, AND THE SUTURE POPPED OFF THE NEEDLE WITH HARDLY ANY PRESSURE OR FORCE. THE SAME ISSUE OCCURRED ON A TOTAL OF 12 SUTURES FROM THE SAME BATCH AND ONE SUTURE FROM A DIFFERENT BATCH NUMBER. THE SURGEON OPENED MORE SUTURES FROM A DIFFERENT BATCH NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542052 ↗
• MalfunctionJun 7, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, SPECIFICALLY DURING THE HIATAL HERNIA REPAIR, THE NEEDLE BROKE WHEN P ASSING THROUGH MUSCLE, AND HALF OF THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT. THE BROKEN HALF OF THE NEEDLE WAS SUCCESSFULLY RETRIEVED WITH A WITH LAPAROSCOPIC HAND INSTRUMENT, AND A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163380 ↗
• InjuryJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE BROKE OFF AND FELL INTO THE CAVITY OF THE PATIENT. IT WAS NOTED THAT PARTIAL PORTION OF THE NEEDLE WAS NOT RETRIEVED

  Patient problems: Foreign Body In Patient

  MAUDE report 22138192 ↗
• InjuryApr 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HIATAL HERNIA REPAIR USING THE INSTRUMENT, THE NEEDLE BROKE DURING SUTURING, AND HALF OF THE NEEDLE WAS LEFT IN THE PATIENT. THE SURGICAL TEAM OPENED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21759801 ↗
• MalfunctionMar 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC DIAPHRAGMATIC PLICATION, DURING PLICATING THE DIAPHRAGM, THE NEEDLES OF THE TWO RELOADS BROKE AND JAMMED ON THE JAWS. THERE WAS DIFFICULTY ON UNLOADING AS WELL WITH THE FIRST RELOAD. THE TWO RELOADS WERE BOTH USED ON THE SAME HANDLE. A NEW INSTRUMENT AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596176 ↗
• MalfunctionMar 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC DIAPHRAGMATIC PLICATION, DURING PLICATING THE DIAPHRAGM, THE NEEDLES OF THE TWO RELOADS BROKE AND JAMMED ON THE JAWS. THERE WAS DIFFICULTY ON UNLOADING AS WELL WITH THE FIRST RELOAD. THE TWO RELOADS WERE BOTH USED ON THE SAME HANDLE. A NEW INSTRUMENT AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596158 ↗
• InjuryJan 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE CLOSING OF THE GASTROJEJUNAL ANASTOMOSIS, THE NEEDLE BROKE IN HALF, AND HALF OF THE NEEDLE WAS EMBEDDED INTO THE TISSUE AT THE GASTROJEJUNUM. THE SURGEON DID NOT IDENTIFY FROM THE INTRA-ABDOMINAL VIEW OR THE ENDOSCOPIC VIEW, SO THE DOCTOR JUST LEAVE THE NEEDLE IN PLACE INSTEAD OF TAKING DOWN THE WHOLE ANASTOMOSIS AND DIGGING IN THE TISSUE BLINDLY. BECAUSE OF THIS, THE PATIENT HAD A SMALL PORTION OF THE NEEDLE STILL INSIDE THE CAVITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21056729 ↗
• MalfunctionDec 3, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE ENDO STITCH INSTRUMENT, THERE WERE DIFFICULTIES ENCOUNTERED WITH THE DEVICE. THE FIRST INSTRUMENT WAS NOT WORKING AS IT SHOULD, IT WOULD NOT OPEN ONCE THE NEEDLE WAS LOADED. WHILE ON THE SECOND INSTRUMENT, THE NEEDLE WAS UNABLE TO BE REMOVED. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH ANOTHER ONE TO COMPLETE THE CASE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833133 ↗
• MalfunctionSep 20, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE OF THE DEVICE BROKE IN TWO AND FELL INSIDE THE PATIENT. BOTH SIDES OF THE NEEDLE WAS ABLE TO BE RETRIEVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271463 ↗
• MalfunctionSep 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX-EN-Y PROCEDURE, WHILE UNLOADING THE DEVICE ON THE BACK TABLE, THE NEEDLE BROKE. THE SURGEON USED A NEW RELOAD WITH THE SAME HANDLE THROUGHOUT THE REST OF THE CASE WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242425 ↗
• InjuryAug 7, 2024Break; Component or Accessory Incompatibility; Human-Device Interface Problem; Break; Component or Accessory Incompatibility; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA REPAIR, DURING PEXYING THE STOMACH TO THE ESOPHAGUS, THE SCRUB NURSE NOTED THAT THE STITCH WAS HARD TO LOAD ONTO THE HANDLE. IT FELT JAMMED AND THE DEVICE WAS DIFFICULT TO TOGGLE. THE NURSE OBSERVED THAT THE DEVICE APPEARED TO BE LOADED THOUGH AND HANDED IT OFF TO THE SURGEON TO USE. UPON THE FIRST BITE OF STOMACH TISSUE FOR THE FUNDOPLICATION, THE NEEDLE SNAPPED IN HALF RIGHT WHERE THE SUTURE WAS GATHERED. THE SURGEON HAD TO RETRIEVE THE NEEDLE FROM THE PATIENT'S STOMACH AND DO A SERIES OF STEPS TO ENSURE THE SAFETY FOR THE PATIENT. AS A PRECAUTION THAT ALL OF THE FOREIGN OBJECTS WERE RETRIEVED, THE SURGEON PERFORMED AN X-RAY AFTER THE SURGICAL PORTION WAS COMPLETED. SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES AND THE SURGEON ENDED UP FREE-STITCHING THE REST OF THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19928419 ↗
• MalfunctionJun 28, 2024Break; Component or Accessory Incompatibility; Break; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A THORACIC PROCEDURE, THE NEEDLE KEEPS BREAKING INSIDE THE HANDLE. IT WAS ALSO REPORTED THAT THE DEVICE WAS DIFFICULT TO LOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19636913 ↗
• MalfunctionMay 24, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA PROCEDURE, THE NEEDLE BROKE AND WAS RETRIEVED DURING SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397855 ↗
• MalfunctionMay 10, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA REPAIR PROCEDURE, WHILE SUTURING, THE SUTURE STRAND BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293284 ↗
• MalfunctionApr 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA REPAIR PROCEDURE, WHILE SUTURING, THE SUTURE STRAND BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164755 ↗
• InjurySep 25, 2023Break; Detachment of Device or Device Component; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR (THORACIC) PROCEDURE, WHILE BEING USED ON THE TISSUE, THE DEVICE WAS DIFFICULT TO TOGGLE AND THE NEEDLE BROKE IN HALF. HALF OF THE NEEDLE REMAINED ON THE HANDLE AND THE OTHER HALF FELL INTO THE PATIENT'S CAVITY. X-RAY WAS THEN BROUGHT INTO THE ROOM TO LOCATE THE NEEDLE. THE SURGEON DETERMINED IT WOULD CAUSE MORE HARM TO OPEN THE PATIENT TO SEARCH FOR THE NEEDLE. THEREFORE, HALF OF THE NEEDLE REMAINED IN THE PATIENT. THIS LED TO 30 MINUTES OR MORE EXTENDED SURGICAL TIME. A NEW HANDLE AND RELOAD WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT HAVE AN EXTENDED RECOVERY PERIOD AND IS HOME.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 17812382 ↗
• MalfunctionAug 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, AT THE TIME OF SUTURING, THE SUTURE WAS LOADED FINE. HOWEVER, THE NEEDLE DETACHED FROM THE SUTURE. A NEW HANDLE WITH A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477201 ↗
• InjuryJul 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 THE LAPAROSCOPIC REVISION OF A SLEEVE, WHEN THE DEVICE WAS TAKEN OUT OF THE PATIENT, THE SURGEON NOTICED THAT THE RIGHT SIDE OF THE NEEDLE AND SUTURE WAS MISSING. THE NEEDLE HAD BROKEN IN HALF. AN X-RAY WAS PERFORMED BUT COULD NOT SAFELY GET TO THE BROKEN NEEDLE. THE RIGHT SIDE OF THE NEEDLE WAS LEFT IN THE PATIENT ALONG WITH THE SUTURE. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES AS THE SURGEON WAIT FOR THE X-RAY AND THEN ATTEMPTED TO GET THE NEEDLE BUT WAS UNSUCCESSFUL. THE CASE WAS STILL ABLE TO BE COMPLETED.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 17246711 ↗
• InjuryMay 18, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE TO BYPASS PROCEDURE, WHEN SUTURING AT THE GASTROESOPHAGEAL JUNCTION AND PASSING THE NEEDLE THROUGH TISSUE, THE NEEDLE BROKE IN HALF. THE PIECE OF THE NEEDLE THAT BROKE OFF INTO THE PATIENT WAS NOT ABLE TO RECOVER. ANOTHER LOADING UNIT WAS OPENED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16953696 ↗
• InjuryMay 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACIC SURGERY (VATS) WHEN PLACATING THE DIAPHRAGM, THE FIRST HANDLE BEING USED BY THE SURGEON JAMMED AND WAS DIFFICULT TO UNLOAD HOWEVER THE DEVICE COULD STILL BE TOGGLED AFTER THE SURGEON TRIED RELOADING THE DEVICE BY HAND. A SECOND DEVICE WAS USED HOWEVER, THE NEEDLE OF THE DEVICE FELL INTO THE PATIENT'S CAVITY AND WAS LOST WITHIN THE DIAPHRAGM FOLD. THE NEEDLE WAS UNABLE TO BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16946950 ↗
• InjuryMay 10, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA PROCEDURE, WHEN SUTURING WITH THE SUTURING DEVICE, PART OF THE SUTURE STRAND FELL OFF INTO THE PATIENT'S CAVITY AND WAS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16903793 ↗
• MalfunctionMar 13, 2023Component 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, PRIOR TO LAPAROSCOPIC ESOPHAGEAL HERNIA REPAIR PROCEDURE, WHEN THE SURGEON LOADED THE SUTURE RELOAD AND THEN WHEN TOGGLING DEVICE, THE NEEDLE FELL OUT OF JAWS. THIS OCCURRED TWO TIMES AND THE NEEDLE FELL ONTO THE BACK TABLE WITH PATIENT BODILY INVOLVEMENT. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529055 ↗
• MalfunctionFeb 13, 2023Break; Component or Accessory Incompatibility; Human-Device Interface Problem; Break; Component or Accessory Incompatibility; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, WHILE ON THE BACK TABLE PRIOR TO USE ON THE PATIENT, THE DEVICE WAS DIFFICULT TO LOAD, TOGGLE, AND UNLOAD. WHEN TRYING TO TOGGLE, THE NEEDLE BROKE. THE BLACK RELOAD BUTTON ALSO BROKE AND FELL ON THE FLOOR. ANOTHER HANDLE 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 16362630 ↗

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