Surgidac 173021Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521129436), received between Apr 6, 2017 and Feb 18, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (12 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Fracture

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377535 ↗
• MalfunctionApr 11, 2021Break; Component or Accessory Incompatibility; Human-Device Interface Problem; Insufficient Device Problem Information; Break; Component or Accessory Incompatibility; Human-Device Interface Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, WHILE THICKER STOMACH WAS BEING WRAPPED AND SUTURED DURING HIATAL HERNIA AND LAPAROSCOPIC NISSEN, THE DEVICE SNAPPED AND BROKE WHEN APPLYING ACROSS STOMACH. IT WAS ALSO NOTED THAT THE SURGEON HAD DIFFICULTY IN TOGGLING AND UNLOADING THE DEVICE. IT WAS ALSO REPORTED THAT THE SURGEON TRIED MULTIPLE LOADING UNITS BUT SOME OF THE LOADING UNITS WERE HARD TO LOAD. THE SAME EVENT OCCURRED ON THREE UNITS OF THE DEVICE. THE SURGEON USED A FREE NEEDLE AND NEEDLE DRIVER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646876 ↗
• MalfunctionJul 10, 2020Entrapment of Device; Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem; Entrapment of Device; Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A MINIMAL INVASIVE ESOPHAGECTOMY, WHILE SUTURING THE STOMACH, BOTH REPORTED INSTRUMENTS WERE DIFFICULT TO LOAD AND THE NEEDLE CAME OUT ON THE FIRST STITCH. ALSO, AFTER SURGEON TOOK A BITE OF TISSUE AND THEN TOGGLED THE NEEDLE, TISSUE STUCK AND SURGEON HAD TO PULL ON INSTRUMENT TO GET NEEDLE DISLODGED. SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10258349 ↗
• MalfunctionJun 29, 2020Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGECTOMY PROCEDURE, WHILE SUTURING AN ANASTOMOSIS, THE NEEDLE BROKE IN THE JAWS OF THE DEVICE. IT WAS ALSO REPORTED THAT THE DEVICE WAS DIFFICULT TO UNLOAD. ANOTHER ENDOSTITCH DEVICE AND RELOAD WERE PULLED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10205448 ↗
• MalfunctionMar 11, 2019Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN PROCEDURE, WHEN THE DEVICE WAS UNLOADED BY TECH, THE NEEDLE BROKE WHILE WAS UNLOADED OUTSIDE OF THE PATIENT. A NEW DEVICE WAS OPENED AND NO FURTHER ISSUE THROUGHOUT THE REST OF THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8410001 ↗
• MalfunctionSep 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MINIMALLY INVASIVE ESOPHAGECTOMY, THE NEEDLE FELL OF WHEN THE SURGEON TOOK A BIT OF TISSUE. IT WAS RETRIEVED FROM THE TISSUE USING GRASPER. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7865910 ↗
• MalfunctionAug 14, 2018Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE TOGGLING OF THE DEVICE WAS NOT SMOOTH ON SOME OF THE RELOADS. SOME WOULD WORK FINE WITH NO ISSUES AND OTHERS WOULD BE DIFFICULT TO TOGGLE. ON TWO OF THE RELOADS, THE STITCH POPPED OFF THE RELOADS AS WELL. THE RELOADS AND DEVICE WERE CONTINUED TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7782486 ↗
• MalfunctionJul 17, 2018Difficult to Open or Close; Human-Device Interface Problem; Mechanical Jam; Difficult to Open or Close; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC NISSEN, THE DEVICE WAS DIFFICULT TO UNLOAD. THE NEEDLE WAS JAMMED CLOSED. THE DEVICE WAS OUTSIDE OF THE PATIENT. THE "BUNNY EARS" WERE ALL THE WAY UP. THE HANDLE WOULD NOT RELEASE OR OPEN. BOTH THE DOCTOR AND TECHNICIAN TRIED TO OPEN MANY TIMES TO REMOVE THE NEEDLE AND LOAD NEW STITCH. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7694192 ↗
• InjuryJun 25, 2018Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE FIRST DEVICE WOULD NOT TOGGLE PROPERLY ON THE VERY FIRST RELOAD. IT WAS DIFFICULT TO LOAD AND UNLOAD AS IT SEEMED TO HAVE BEEN MISALIGNED. THEY WORKED ON THE TOGGLES TO "LOOSEN" IT UP AND WERE ABLE TO FINISH THE STITCH BUT REQUESTED A NEW HANDLE. THE SUTURE WAS ALSO FRAYING CLOSE TO THE NEEDLE. THE SECOND DEVICE HAD DIFFICULTY TOGGLING THROUGH THICK TISSUE. THE SURGEON SAID SHE HAD TO WORK INTO THE TISSUE TO GET IT TO TOGGLE. THE NEEDLE WOULD NOT TRANSFER EASILY IT LEFT A SLIGHT LARGER HOLE IN THE TISSUE BECAUSE THE TISSUE NEEDED TO BE REMOVED FROM THE DEVICE WITH A GRASPER. IT WAS OVER SEWN.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7633687 ↗
• MalfunctionJun 21, 2018Detachment Of Device Component; Human-Device Interface Problem; Detachment Of Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHILE OVER SEWING STAPLE LINE, THE DEVICE WAS DIFFICULT TO TOGGLE, LOAD AND UNLOAD AND THE NEEDLE FELL OFF INTO PATIENT'S CAVITY TWICE. IT WAS RETRIEVED WITH GRASPERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7625637 ↗
• MalfunctionMay 17, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, THE SUTURE AND THE NEEDLE SEPARATED WHEN APPLIED ON GASTRIC POUCH CREATION. A NEW SUTURE WAS LOADED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522292 ↗
• MalfunctionMar 9, 2018Break; Detachment Of Device Component; Human-Device Interface Problem; Break; Detachment Of Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) PROCEDURE. THE SUTURING DEVICE WAS DIFFICULT TO LOAD AND UNLOAD. THERE WERE NO ISSUES USING THE DEVICE. FOUR NEEDLES ALSO BROKE. ONE HALF OF THE NEEDLE IS STILL LOADED IN THE DEVICE. ALL OF THE NEEDLE WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7328506 ↗
• MalfunctionOct 16, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE ON (B)(6)2017,THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT. THE NEEDLE WAS RETRIEVED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6951192 ↗
• MalfunctionOct 9, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROUX-EN-Y LAPAROSCOPIC PROCEDURE, WHILE CLOSING A DEFECT IN THE BOWEL, THE SUTURE SEPARATED FROM THE SWEDGE OF THE NEEDLE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS THE NEEDLE IS NOW STUCK IN THE DEVICE THIS IS ONLY BECAUSE THE SURGEON BROKE THE DEVICE OVER HIS KNEE SO IT WILL NOT BE IN WORKING CONDITION. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6931655 ↗
• MalfunctionAug 21, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: PER ADDITIONAL INFORMATION RECEIVED THE SUTURE FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED USING A GRASPER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6808353 ↗
• MalfunctionAug 6, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC ESOPHAGECTOMY, THE DEVICE WAS DIFFICULT TO TOGGLE WHILE IN THE TISSUE. THE DEVICE HAD TO BE PRIED OPEN BY PUSHING THE BLACK BUTTONS OF THE DEVICE UP TO REMOVE THE NEEDLE FROM THE TISSUE. NO TISSUE WAS TORN AND THE NEEDLE WAS RECOVERED AFTER IT FELL FROM PATIENT'S CAVITY. A NEW DEVICE WAS OPENED AND THE SAME TECHNIQUE WAS EMPLOYED AND THE NEW DEVICE WORKED AS IT SHOULD WITH NO DIFFICULTY. WHEN OPENING THE DEVICE IT WAS REPORTED THAT THEY COULD HEAR THE "GEARS GRINDING" IN THE DEVICE. NO PATIENT'S INJURY WAS NOTED ON THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6769870 ↗
• MalfunctionJul 12, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS. WHILE OVERSEWING THE STAPLE LINE, THE SUTURE SLIPPED OUT OF THE SWAGE OF THE NEEDLE. NOTHING DISENGAGED INTO THE PATIENT CAVITY. TO COMPLETE THE PROCEDURE, ANOTHER LOADING UNIT WAS USED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708154 ↗
• MalfunctionJul 12, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS. WHILE OVERSEWING THE STAPLE LINE, THE SUTURE SLIPPED OUT OF THE SWAGE OF THE NEEDLE. NOTHING DISENGAGED INTO THE PATIENT CAVITY. TO COMPLETE THE PROCEDURE, ANOTHER RELOAD WAS OPENED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708076 ↗
• MalfunctionJul 3, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC BAND REVISION TO ROUX-EN-Y PROCEDURE. THE SUTURES WERE BEING USED FOR THE ANASTOMOSIS. FOR THE FIRST SUTURE RELOAD, THE NEEDLE FELL INTO THE PATIENT AND WAS RETRIEVED BY GRASPER. FOR THE SECOND SUTURE RELOAD, THE NEEDLE DISLODGED FROM THE SUTURING DEVICE. FOR THE THIRD SUTURE RELOAD, THERE WAS DIFFICULT LOADING THE RELOAD. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, OPENED NEW SUTURE RELOADS. THERE WAS NO PATIENT HARM. THE PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6683867 ↗
• MalfunctionJul 3, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC BAND REVISION TO ROUX-EN-Y PROCEDURE. THE SUTURES WERE BEING USED FOR THE ANASTOMOSIS. FOR THE FIRST SUTURE RELOAD, THE NEEDLE FELL INTO THE PATIENT AND WAS RETRIEVED BY GRASPER. FOR THE SECOND SUTURE RELOAD, THE NEEDLE DISLODGED FROM THE SUTURING DEVICE. FOR THE THIRD SUTURE RELOAD, THERE WAS DIFFICULT LOADING THE RELOAD. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, OPENED NEW SUTURE RELOADS. THERE WAS NO PATIENT HARM. THE PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6683865 ↗
• MalfunctionJun 27, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS. WHILE SUTURING THE ANASTOMOSIS, THE NEEDLE DISENGAGED. IT DID NOT DISENGAGE INTO THE PATIENT CAVITY. TO COMPLETE THE PROCEDURE, ANOTHER LOADING UNIT WAS USED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6669304 ↗
• MalfunctionJun 22, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC ROUX-EN-Y PROCEDURE. THE SUTURE CAME OFF THE NEEDLE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, OPENED A NEW NEEDLE RELOAD. THERE WAS NO PATIENT HARM. THE PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6662591 ↗
• MalfunctionJun 22, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC ROUX-EN-Y PROCEDURE. THE SUTURING DEVICE WAS BEING USED FOR THE ANASTOMOSIS. THE SUTURE CAME OFF OF THE NEEDLE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, OPENED A NEW NEEDLE RELOAD. THERE WAS NO PATIENT HARM. THE PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6662584 ↗
• MalfunctionJun 20, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAP ROUX-EN-Y REVISION, THE SUTURE CAME OFF THE NEEDLE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6654345 ↗
• MalfunctionJun 5, 2017Detachment Of Device Component; Human-Device Interface Problem; Detachment Of Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING THE LAPAROSCOPIC HERNIA REPAIR, THE SURGEON WAS PLACING THE NEEDLE THROUGH THE MESH AND THEN THROUGH THE TISSUE WHEN THE NEEDLE DISENGAGED AND IT WAS ALSO DIFFICULT TO LOAD AND UNLOAD. THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT AND IT WAS RETRIEVED USING A GRASPER. THE PATIENT IS ALIVE AND HAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6610589 ↗

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