Surgidac 173023Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10884521129443), received between Nov 23, 2016 and Feb 17, 2026 — classified as 11 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (24 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Break; Detachment of Device or Device Component; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INSERTION OF A MEDIPORT, AFTER TWO SUCCESSFUL DEVICE USES WHEN SUTURING THE SURROUNDING TISSUE OF THE CATHETHER TO THE ABDOMINAL WALL, THE DEVICE WAS RELOADED BY THE SCRUB NURSE AND HANDED OFF TO THE SURGEON. THE DEVICE WAS CYCLED, THEN THE SURGEON INSERTED IT IN THE CAVITY OF THE PATIENT, PLACED THE TISSUE BETWEEN THE JAWS OF THE INSTRUMENT, CLOSED THE JAWS AND CYCLED THE INSTRUMENT, HOWEVER THE NEEDLE DID NOT GO THROUGH THE TISSUE AND WAS LODGED IN THE ABDOMEN. ATTEMPTS TO PULL THE SUTURE OUT WITH THE NEEDLE IN THE PATIENT'S ABDOMEN WERE UNSUCCESSFUL AND THEN THE NEEDLE BROKE OFF THE SUTURE. THE NEEDLE WAS LEFT IN THE ABDOMEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 24361610 ↗
• MalfunctionJan 10, 2023Component or Accessory Incompatibility; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Component or Accessory Incompatibility; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC MINI GASTRIC BYPASS, WHILE TAKING OVER THE FUNDUS PRIOR TO FIRING THE RELOAD COULD NOT BE LOADED INTO THE INSTRUMENT. IT WAS ALSO STATED THAT THERE WAS DIFFICULTY TO TOGGLE AND UNLOAD. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES SINCE THE OLD INSTRUMENT FROM THE PREVIOUS CASE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134849 ↗
• MalfunctionNov 18, 2019Detachment 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 SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT TO TOGGLE. IT WAS ALSO REPORTED THAT THE NEEDLE FELL OUT OF THE INSTRUMENT AND WAS RETRIEVED WITH A NEEDLE HOLDER. THE NEEDLE WAS REMOVED FROM THE PATIENT'S CAVITY AND PLACED ON THE NEEDLE COUNT SHEET MAKING SURE THAT ALL PIECES WERE LOCATED. A NEW LOADING UNIT AND INSTRUMENT WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9336219 ↗
• MalfunctionNov 13, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS, WHILE ON STOMACH AND SMALL BOWEL, AS THE DEVICE TOGGLED BACK AND FORTH IN THE STOMACH, IT WAS GETTING STUCK ON THE TISSUE INSTEAD OF BEING DISLODGED. THE SURGICAL TECHNICIAN HAD TO WIGGLE IT OUT OF THE APPLIED TISSUE SEVERAL TIMES TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9316469 ↗
• MalfunctionOct 23, 2019Break; Component or Accessory Incompatibility; Human-Device Interface Problem; Break; Component or Accessory Incompatibility; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, WHILE SUTURING THE STOMACH DURING A LAPAROSCOPIC ESOPHAGECTOMY, THE TECHNICIAN COULD NOT LOAD OR UNLOAD THE DEVICES EASILY. THE NEEDLE BROKE IN HALF WHILE LOADING. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9227746 ↗
• MalfunctionSep 30, 2019Break; 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 PROCEDURE, THE TECHNICIAN HAD DIFFICULTY ON LOADING THE DEVICE, AND THE NEEDLE GOT STUCK IN THE HANDLE AND THEN WAS UNABLE TO BE UNLOADED. THE NEEDLE BROKE IN HALF WHILE TRYING TO UNLOAD. THIS DEVICE NEVER TOUCHED THE PATIENT AND WAS NEVER IN THE SURGEON'S HANDS. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9137885 ↗
• InjuryJul 25, 2019Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA PROCEDURE, WHILE SUTURING THE DIAPHRAGM, THE DEVICE HAD DIFFICULTY IN TOGGLING AND UNLOADING, THEN THE NEEDLE FELT IN THE PATIENT'S DIAPHRAGM AND WAS NOT RETRIEVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8829452 ↗
• MalfunctionJun 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAP ROUX-EN-Y BARIATRIC SURGERY, WHEN CLOSING THE SPACE OF PETERSEN, THE SUTURE POPPED OFF FROM THE NEEDLE AS THE SURGEON WAS TOGGLING THE DEVICE TO CLOSE THE DEFECT. THEY OPENED A NEW RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8671947 ↗
• MalfunctionMay 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX EN Y PROCEDURE, THE SURGEON WAS CLOSING THE SPACE OF DEFECT AND AS THEY WERE TOGGLING, THE SUTURE RIPPED OFF THE NEEDLE. ANOTHER LOADING UNIT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626077 ↗
• MalfunctionMay 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE, THE SURGEON WAS USING INSTRUMENT WITH PLEDGETS WHEN THE SUTURE DETACHED FROM THE NEEDLE. ANOTHER LOADING UNIT WAS OPENED TO COMPLETE THE PROCEDURE AND THE SUTURE WAS RETRIEVE USING A GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8623812 ↗
• MalfunctionMay 17, 2019Detachment 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 SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT TO TOGGLE AND UNLOAD. THEN TWO NEEDLES FELL OUT OF THE JAWS ON THE SAME HANDLE. THE RABBIT EARS WERE REPORTED NOT TO BE VISIBLE. THE DEVICE WAS PROPERLY LOADED BUT THE NEEDLES FELL OUT OF THE HANDLE INTO THE PATIENT'S CAVITY. IT WAS ALSO NOTED THAT NEEDLES WERE RETRIEVED. OPENED A NEW HANDLE AND LOADING UNIT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621880 ↗
• MalfunctionApr 16, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC NISSEN HIATAL HERNIA, WHILE PASSING THROUGH TISSUE, THE DEVICE WAS DIFFICULT TO TOGGLE. A SECOND DEVICE WAS OPENED, HOWEVER THE DEVICE WAS ALSO DIFFICULT TO TOGGLE AND THE NEEDLE BROKE IN TWO PARTS IN TWO DIFFERENT TIMES. IT WAS STATED THAT ONE FELL INTO THE CAVITY, BUT WAS RETRIEVED. ANOTHER HANDLE AND RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520260 ↗
• MalfunctionApr 16, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC NISSEN HIATAL HERNIA, WHILE PASSING THROUGH TISSUE, THE DEVICE WAS DIFFICULT TO TOGGLE. A SECOND DEVICE WAS OPENED, HOWEVER THE DEVICE WAS ALSO DIFFICULT TO TOGGLE AND THE NEEDLE BROKE IN TWO PARTS IN TWO DIFFERENT TIMES. IT WAS STATED THAT ONE FELL INTO THE CAVITY, BUT WAS RETRIEVED. ANOTHER HANDLE AND RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520234 ↗
• InjuryMar 27, 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 LAPAROSCOPIC NISSEN PROCEDURE, WHILE THE DEVICE WAS BEING USED TO CLOSE THE HIATAL HERNIA AND WRAP OF STOMACH, THE NEEDLE FELL OUT ONCE AND DISENGAGED INTO THE PATIENT'S CAVITY. AN X-RAY WAS PERFORMED TO LOCATE THE COMPONENT AND WAS RETRIEVED BY A GRASPER. THE SURGEON CHANGED THE HANDLE 3 TIMES BECAUSE IT WAS VERY DIFFICULTY TO LOAD AND UNLOAD.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8458532 ↗
• MalfunctionFeb 15, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A SURGERY FOR A GASTRIC RESTRICTIVE PROCEDURE WITH GASTRIC BYPASS AND ROUX EN Y GASTROENTEROSTOMY, THE SUTURE NEEDLE BROKEN IN HALF WHILE UNLOADING FORM THE SUTURE PASSER ON THE BACK TABLE. BOTH PARTS OF THE NEEDLE WERE ACCOUNTED FOR. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8343489 ↗
• MalfunctionDec 20, 2018Difficult or Delayed Positioning; Human-Device Interface Problem; Difficult or Delayed Positioning; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT TO TOGGLE AND THE NEEDLE WOULD NOT GO THROUGH THE TISSUE. WHEN REMOVED IN STERILE FIELD, DEVICE TOGGLED FINE BUT WHEN APPLIED TO TISSUE IT REQUIRED TWO HANDS TO GET THE DEVICE TO TOGGLE TO THE OTHER SIDE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8187738 ↗
• MalfunctionNov 28, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EX-Y, WHILE CLOSING THE ENTEROTOMY OF THE JEJUNUM, ONE HALF OF THE NEEDLE FELL INTO THE PATIENT'S CAVITY. THE DOCTOR RETRIEVED THE BROKEN NEEDLE USING A GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8110100 ↗
• MalfunctionNov 27, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN LAPAROSCOPIC IVOR LEWIS ESOPHAGECTOMY PROCEDURE, THE DEVICE NEEDLE BROKE IN HALF AND FELL INTO THE PATIENT CAVITY. TO RESOLVE THE ISSUE THE SURGEON ABLE TO RETRIEVED THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8106977 ↗
• InjuryOct 12, 2018Break; Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE DEVICE WAS DIFFICULT TO TOGGLE, LOAD AND UNLOAD AND WHEN THE SURGEON WAS SEWING THE GASTRIC POUCH, THE NEEDLE BROKE IN HALF AFTER PASSING THROUGH THE TISSUE. THEY COULD NOT FIND THE NEEDLE AND WAS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7960441 ↗
• MalfunctionOct 2, 2018Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER: THE NEEDLE FELL OUT OF THE DEVICE AND FELL INTO THE PATIENT'S CAVITY DURING LAPAROSCOPIC SUBTOTAL GASTRECTOMY WHILE ON ANASTOMOSIS. THE NEEDLE WAS RETRIEVED WITH A GRASPER. THEY ALSO REPORTED THAT THE DEVICE WAS DIFFICULT TO TOGGLE AND UNLOAD. THEY THEN USED A NEW DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7926494 ↗
• MalfunctionAug 31, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN SUTURING THE HERNIA DEFECT DURING A LAPAROSCOPIC HIATAL HERNIA, THE NEEDLE BROKE AND HALF OF IT FELL INTO THE PATIENT CAVITY BUT THE SURGEON ABLE TO RETRIEVED IT. A NEW RELOAD WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837791 ↗
• MalfunctionAug 31, 2018Component 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, WHILE REPAIRING THE DEFECT AT THE GASTROESOPHAGEAL JUNCTION DURING A LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR, THE SUTURES WERE DISLODGED FROM THE DEVICE BUT NOTHING FELL INTO THE PATIENT'S CAVITY. IT WAS ALSO REPORTED THAT THE DEVICES WERE DIFFICULT TO TOGGLE, LOAD AND UNLOAD. THEY OPENED AND USED ANOTHER SUTURES TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837691 ↗
• MalfunctionAug 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS, WHILE THEY WERE ANCHORING THE SMALL BOWEL TO STOMACH TO FIND LATER AND PULLING BACK TO TIGHTEN THE KNOT, THE SUTURE DISENGAGED FROM NEEDLE AND REMAINED ON THE DEVICE. THE SUTURE WAS TIED LAPAROSCOPICALLY TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7822992 ↗
• InjuryJun 27, 2018Difficult or Delayed Positioning; Entrapment of Device; Human-Device Interface Problem; Difficult or Delayed Positioning; Entrapment of Device; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, WHILE ATTEMPTING TO OVER SEW THE ANASTOMOSIS ON A LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS, THE SURGEON WAS UNABLE TO TOGGLE THE NEEDLE TO THE OTHER JAW. THE TISSUE WAS TENTING AROUND THE NEEDLE, HOWEVER THE NEEDLE WOULD NOT PIERCE COMPLETELY THROUGH. THIS RESULTED IN TISSUE BEING JAMMED INTO THE OTHER JAW WITH THE NEEDLE. THE SURGEON TRIED A NUMBER OF TIMES TO TOGGLE BACK AND FORTH THROUGH THE TISSUE BUT UNABLE TO COMPLETE THE TRANSITION OF THE NEEDLE FROM THE JAW TO THE OTHER. THE SURGEON STRUGGLED TO REMOVED THE NEEDLE FROM THE TISSUE AND EXPERIENCED SOME SEROSAL TEARING WHILE USING GRASPER TO REMOVE TISSUE FROM THE NEEDLE. THIS RESULTED TO EXTENDED TIME OF MORE THAN 30 MINUTES DUE TO THE SURGEON USED STANDARD LAPAROSCOPIC SUTURE AND NEEDLE DRIVERS IN PLACE OF THE DEVICE TO COMPLETE THE CASE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7642930 ↗
• MalfunctionApr 18, 2018Detachment Of Device Component; Human-Device Interface Problem; Detachment Of Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC ROUX EN Y, WHEN SUTURING THE JEJUNUM, THE DEVICE WAS DIFFICULT TO TOGGLE, LOAD AND UNLOAD. THE NEEDLE FELL OUT OF THE DEVICE'S JAWS INTO THE PATIENT ABDOMEN AND WAS RETRIEVED USING A GRASPER. A NEW DEVICE AND SUTURE WAS OPENED AND LOADED TO COMPLETE THE CASE. THE PATIENT HAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441675 ↗

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