Surgidac 173026Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521129467), received between Aug 14, 2017 and Aug 20, 2020 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2020Entrapment of Device; Human-Device Interface Problem; Entrapment of Device; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HIATAL HERNIA REPAIR PROCEDURE, WHEN THE SURGEON USING THE DEVICE IT WAS DIFFICULT TO TOGGLE, SO THE SURGEON SQUEEZED VERY HARD ON THE WHITE HANDLES AND THEY BOTH BROKE THAT RESULTED TO THE JAWS OF THE DEVICE WERE UNABLE TO OPEN AND REMOVED FROM TISSUE. TO RESOLVE THE ISSUE, THE SURGEON GET A SET OF LAPAROSCOPIC GRASPERS INTO THE JAWS OF THE INSTRUMENT AND FORCE THE INSTRUMENT TO OPEN AND RELEASE FROM THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435193 ↗
• 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 MINIMALLY 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 THE SURGEON HAD TO PULL ON AN INSTRUMENT TO GET NEEDLE DISLODGED. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10259564 ↗
• MalfunctionMar 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE WRAPPING THE STOMACH AROUND THE ESOPHAGUS DURING A LAPAROSCOPIC NISSEN PROCEDURE, THE SUTURE FELL OFF THE NEEDLE. IT WAS ALSO REPORTED THAT THE NEEDLE DISENGAGED INTO THE PATIENT'S CAVITY BUT WAS RETRIEVED USING A LAPAROSCOPIC GRASPER. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9805283 ↗
• MalfunctionApr 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN OVER SEWING THE STOMACH DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE TWO NEEDLES DROPPED INTO THE PATIENT¿S CAVITY TWICE FROM THE HANDLE WHILE PASSING. IT WAS STATED THAT THE NEEDLE WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. THEY REMOVED THE NEEDLES RELOADED THE DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520511 ↗
• MalfunctionOct 5, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GASTRIC BYPASS PROCEDURE, THE NEEDLE BROKE WHILE STITCHING THE PATIENT'S STOMACH. THE NEEDLE WAS RECOVERED PRIOR TO THE END OF THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7938815 ↗
• MalfunctionSep 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS, WHILE SUTURING MESENTERIC DEFECT AND WHEN THEY WENT TO TIE SUTURE TIGHT, THE SUTURE BECAME DISENGAGED FROM THE NEEDLE. THE SUTURE WAS TIED LAPAROSCOPICALLY TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845709 ↗
• MalfunctionSep 4, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHEN THE DOCTOR WAS SUTURING THE PURSE STRING AROUND THE ANVIL TO CONNECT THE SMALL INTESTINES TO THE STOMACH AND DURING FIRST THROW OF THE DEVICE THE NEEDLE BROKE AND HALF OF IT FELL INTO THE CAVITY OF THE PATIENT. THE NEEDLE WAS LOCATED AFTER SCOPING THE ESOPHAGUS AND STOMACH. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM TO LOCATE THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7842782 ↗
• MalfunctionAug 14, 2018Component or Accessory Incompatibility; Detachment of Device or Device Component; Component or Accessory Incompatibility; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, ON SUTURING, IT WAS VERY HARD TO LOAD THE PRODUCT AND AFTER MANY TRIALS THEY SUCCEEDED TO RELOAD IT BUT THE NEEDLE WAS DETACHED SO THEY NEEDED TO CHANGE THE SUTURE 5 TIMES AND THE HANDLE AS WELL TO COMPLETE THE CASE. THE COMPONENTS DID NOT FALL INTO THE CAVITY OF THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7780942 ↗
• MalfunctionMar 6, 2018Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. THE SUTURING DEVICE WAS BEING USED TO SUTURE VERY THICK TISSUE. ONCE IT WAS REMOVED FROM THE PATIENT, IT WAS DIFFICULT TO UNLOAD THE NEEDLE. IT JAMMED AND THE NEEDLE BROKE OUTSIDE OF THE PATIENT. THERE IS STILL A SMALL PIECE OF THE NEEDLE IN THE JAW OF THE SUTURING DEVICE AND THE REST OF THE NEEDLE WAS RETRIEVED FROM THE FLOOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7318166 ↗
• MalfunctionSep 29, 2017Detachment Of Device Component; Human-Device Interface Problem; Detachment Of Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER: DURING THE LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE, THE SUTURING DEVICE DOES NOT HOLD THE STITCH PROPERLY. THE DEVICE WAS DIFFICULT TO TOGGLE. THE NEEDLE DISENGAGED FROM THE DEVICE. IT COULD NOT BE USED. SURGERY WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. THERE WAS BLOOD IN HER URINE AND SHE HAD TO WEAR A CATHETER FOR A WEEK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6903847 ↗
• MalfunctionAug 25, 2017Detachment Of Device Component; Detachment of Device or Device Component; Human-Device Interface Problem; Detachment Of Device Component; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HIATAL HERNIA REPAIR PROCEDURE, THE DEVICE HAD DIFFICULTY TO LOAD. THE NEEDLE DID NOT STAY AND FELL INTO PATIENT'S CAVITY AND NO INFORMATION YET ON IF IT WAS OR HOW IT WAS RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6821347 ↗
• MalfunctionAug 14, 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 HIATAL HERNIA PROCEDURE. THE SUTURING DEVICE WAS BEING USED FOR CLOSING THE HERNIA DEFECT. WHILE SYNCHING DOWN ON THE SUTURE TO TIE THE KNOT, THE SUTURE BROKE FROM THE NEEDLE. THE SUTURE FELL INTO THE CAVITY OF THE PATIENT BUT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, A NEW RELOAD WAS OPENED AND USED. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6791433 ↗

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