Endo Stitch 173016Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,333 adverse event reports that list this exact device (DI 10884521100008), received between Jun 27, 2016 and Sep 24, 2026 — classified as 1 death, 298 injuries, 1,034 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (485 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 1,333 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  It was reported that during a laparoscopic inguinal hernia repair procedure, the needle broke. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877113 ↗
• MalfunctionSep 23, 2026Component or Accessory Incompatibility; Detachment of Device or Device Component

  It was reported that during a laparoscopic hysterectomy, the device was used to close the vaginal cuff. One reload was used successfully; however, a second reload could not be loaded properly. A subsequent reload was loaded, and during use, a portion of the needle broke off and fell into the patient¿s abdomen. X-ray imaging performed on (b)(6) 2026, visualized the needle fragment in the abdomen. The physician re-entered the abdomen and attempted to locate the fragment but was unable to find it. The fragment was intentionally left in the patient because the physician determined that conversion to an open procedure to attempt retrieval was not preferable. Surgical time was extended by 30 minutes or more.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 50863576 ↗
• MalfunctionSep 22, 2026Detachment of Device or Device Component; Human-Device Interface Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862819 ↗
• MalfunctionSep 15, 2026Detachment of Device or Device Component

  It was reported that during laparoscopic hysterectomy for vaginal cuff closure, when the physician opened the device after taking the first bite of tissue, the suture and part of the needle disengaged. The needle and suture fell into the patient cavity and were retrieved by the physician. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766479 ↗
• MalfunctionSep 4, 2026Detachment of Device or Device Component

  It was reported that during a laparoscopic hysterectomy, the needle disengaged from the device. A second handle was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600962 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226851 ↗
• MalfunctionAug 4, 2026Component or Accessory Incompatibility; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129974 ↗
• InjuryJul 28, 2026Detachment of Device or Device Component

  According to the reporter, during a laparoscopically assisted vaginal hysterectomy, when the endo stitch was used to close the vaginal cuff, the needle broke off. An x-ray was done and the needle was retrieved. The surgeon used a traditional needle driver to complete the case.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 50061146 ↗
• MalfunctionJul 1, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH VAGINAL CUFF CLOSURE, THE THREE NEEDLES WAS REPORTED TO HAVE BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682373 ↗
• InjuryJun 24, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION, ESOPHAGOGASTRODUODENOSCOPY, THE DEVICE WAS DROPPED FROM SUTURING DEVICE DUE TO MALFUNCTION WHILE SUTURING TISSUE. THERE WAS MORE PATIENT TRAUMA TRYING TO REMOVE THE NEEDLE THAN TO LEAVE IT BEHIND. THE NEEDLE WAS SEEN AND WAS NO RETRIEVED ON POST-OP X-RAY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 25610879 ↗
• InjuryJun 19, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DUODENAL SWITCH, WHILE APPROXIMATING THE SMALL BOWEL, THE SURGEON HAD COMPLETED THE USE OF THE SUTURE, THE DEVICE WORKED COMPLETELY FINE. ONCE THE SURGEON HAD CUT THE SUTURE TO TAKE THE ENDOSTITCH DEVICE OUT OF THE ABDOMEN, THE NEEDLE HAD FALLEN LOSE AND IT WAS LOST IN THE OPERATING ROOM. THE C-ARM WAS BROUGHT INTO THE ROOM TO SEE IF THE NEEDLE COULD BE FOUND INSIDE THE PATIENT¿S ABDOMEN, BUT THE RESULT CAME BACK NEGATIVE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THE ENDOSTITCH DEVICE WAS USED AGAIN WITH NO ISSUE, BUT THE NEEDLE WAS UNABLE TO BE FOUND.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 25559904 ↗
• MalfunctionJun 5, 2026

  "MALFUNCTION OF ENDO STITCH SUTURING DEVICE, REFERENCE NUMBER 173016. LOT J5E3790EY, UDI: (B)(4). DURING PROCEDURE, 0 SILK ES-9 ENDO-NEEDLE WAS DROPPED FROM SUTURING DEVICE DUE TO MALFUNCTION WHILE SUTURING TISSUE. PER DR. [REDACTED], IT WOULD CAUSE MORE PATIENT TRAUMA TRYING TO REMOVE THE NEEDLE THAN TO LEAVE IT BEHIND. EVENT WAS DOCUMENTED IN SURGICAL COUNTS AND NEEDLE WAS DOCUMENTED AS A RETAINED PACKED ITEM IN FLOWSHEETS/AVATAR. NEEDLE WAS SEEN AND VERIFIED BY SURGEON ON POST-OP XRAY. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408140 ↗
• MalfunctionMay 3, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF TOTAL LAPAROSCOPIC HYSTERECTOMY, WHILE THE SCRUB TECHNICIAN WAS LOADING A NEW RELOAD DURING VAGINAL CUFF CLOSURE, THE BLACK RELEASE BUTTON ON THE HANDLE BROKE OFF. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER HANDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25064298 ↗
• InjuryApr 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE WAS USED AND THE NEEDLE BROKE OFF. IT WAS REPORTED THAT THE NEEDLE FRAGMENT REMAINED IN THE PATIENT¿S TISSUE AND WAS UNRETRIEVABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25050287 ↗
• InjuryApr 22, 2026Detachment of Device or Device Component; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION, THE NEEDLE WAS NOT ON A SECURED LOCKED POSITION. THE NEEDLE WAS LOADED IN DEVICE IN THE USUAL FASHION AND ONE STITCH WAS PLACED AFTER WHICH IT WAS NOTED THE NEEDLE WAS ROTATED AND WAS NOT ALLOWING IT TO CLOSE PROPERLY AND CONTINUE USING THE DEVICE TO SUTURE. THE JAWS DID NOT CLOSE COMPLETELY ON THE NEEDLE AFTER THE SUTURE WAS PASSED THROUGH TISSUE AND THE PROVIDER WAS UNABLE TO SHUTTLE THE NEEDLE BACK AND FORTH IN THE DEVICE. THE SURGEON CLOSED THE DEVICE AS BEST AS POSSIBLE TO REMOVE THE NEEDLE FROM PATIENT. THE DEVICE WAS REMOVED AND PASSED TO THE SCRUB NURSE, WHERE IT WAS NOTED THAT THERE WAS NO NEEDLE IN THE DEVICE OR ON THE SUTURE. THERE WAS NO VISUALIZATION OF NEEDLE DROPPING IN THE PERITONEAL CAVITY. THE DEVICE WAS ONLY PARTIALLY VISUALIZED DURING REMOVAL AND WAS NOT VISUALIZED AS IT EXITED THE PORT. IT WAS NOTED THAT THE LOCATION OF NEEDLE WAS UNDETERMINED. THE USER LOOKED IN THE PERITONEAL CAVITY AND WAS UNABLE TO LOCATE. EXTENSIVE SEARCH WAS DONE OUTSIDE THE PATIENT AND THE USER FAILED TO LOCATE THE NEEDLE AS WELL. THE DEVICE WAS USED APPROXIMATELY FOUR MORE TIMES WITHOUT ISSUE AFTER THE INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24954676 ↗
• InjuryApr 14, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL PROCEDURE, THE NEEDLE CAME OFF FROM THE DEVICE AND COULD NOT BE SAFELY RETRIEVED FROM THE PATIENT WITHOUT RISKING FURTHER HARM. THE PATIENT RECEIVED POSTOPERATIVE 40 MG SUBCUTANEOUS INJECTION AS PART OF STANDARD CARE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24877316 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHILE BEING PASSED THROUGH THE VAGINAL CUFF FOR VAGINAL CUFF CLOSURE, THE NEEDLE BROKE. UPON EXITING THE CUFF, THE SURGEON NOTICED ABOUT 4MM OF THE NEEDLE WAS MISSING. A NEW PRODUCT WAS OPENED TO COMPLETE THE VAGINAL CUFF CLOSURE. THE MISSING PORTION COULD NOT BE LOCATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829718 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TOTAL LAPAROSCOPIC HYSTERECTOMY WHILE CLOSING THE VAGINAL CUFF, THERE WERE NO ISSUES WITH LOADING OR TOGGLING OF THE DEVICE, HOWEVER, WHEN THE SURGEON ATTEMPTED TO TAKE A BITE OF TISSUE, THE NEEDLE FELL OUT OF THE DEVICE. THE ISSUE OCCURRED ON THREE SUTURES. THE NEEDLE COMPONENTS FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED WITH A GRASPER. A NEW INSTRUMENT AND SUTURE WAS OPENED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693046 ↗
• InjuryMar 19, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, A LAPAROSCOPIC HYSTERECTOMY WAS UNCOMPLICATED UNTIL CLOSURE. THE VAGINAL CUFF WAS CLOSED USING THE DEVICE. WHEN THE BACK SUTURE WAS PERFORMED TO LOCK THE SUTURE IN PLACE, THE NEEDLE WAS TOGGLED, BECAME EMBEDDED IN TISSUE, AND DISLODGED FROM THE DEVICE. UPON REMOVAL, THE SUTURE BROKE OFF FROM THE NEEDLE, WHICH REMAINED RETAINED IN THE VAGINAL CUFF. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE NEEDLE VAGINALLY AND LAPAROSCOPICALLY. C-ARM FLUOROSCOPY DEMONSTRATED THE NEEDLE IN SITU NEAR THE LEFT PUBIC RAMUS, RAISING CONCERN THAT THE NEEDLE WAS LOCATED IN THE VAGINAL CUFF. THE NEEDLE WAS UNABLE TO BE PALPATED OR LOCATED IN THE RESECTED TISSUE. A MAGNET WAS USED IN ATTEMPTS TO LOCATE THE NEEDLE LAPAROSCOPICALLY AND VAGINALLY WITHOUT SUCCESS. TISSUE WAS RESECTED; HOWEVER, DUE TO PROXIMITY TO THE BLADDER EDGE AND NEAR A VASCULAR PEDICLE, THE DECISION WAS MADE TO ABANDON FURTHER ATTEMPTS AT REMOVAL AND TO CLOSE THE CUFF.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 24638102 ↗
• InjuryMar 13, 2026Break; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY, WHILE USING THE SUTURING INSTRUMENT TO CLOSE THE VAGINAL CUFF AFTER REMOVAL OF THE CERVIX AND UTERUS, THE DEVICE WAS DIFFICULT TO UNLOAD AND THE STRING FELL OUT AFTER THE FIRST BITE, AND UPON REMOVAL OF THE SUTURING DEVICE, OPERATING ROOM STAFF NOTICED A PIECE OF THE NEEDLE WAS MISSING AND IMMEDIATELY INFORMED THE PHYSICIAN. AN INTRAOPERATIVE X-RAY WAS PERFORMED TO LOCATE THE RETAINED NEEDLE FRAGMENT. ATTEMPTS TO LOCATE THE DEVICE LED TO INCREASED BLEEDING DURING SURGERY, PROLONGED ANESTHESIA TIME DUE TO EXTENDED SURGICAL TIME OF MORE THAN 30 MINUTES, AND THE INSERTION OF AN ADDITIONAL TROCAR, RESULTING IN ANOTHER SCAR. THE CUFF WAS CLOSED VAGINALLY, HEMOSTASIS WAS ACHIEVED, AND AFTER LOCATING THE NEEDLE FRAGMENT ON X-RAY BUT BEING UNABLE TO RETRIEVE IT DUE TO PATIENT BLEEDING, THE SURGICAL TEAM DECIDED NOT TO INTERVENE FURTHER.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Laceration(s); Unintended Radiation Exposure

  MAUDE report 24599470 ↗
• InjuryMar 10, 2026Break

  ACCORDING TO THE REPORTER, DURING SUTURING OF A VAGINAL CUFF, THE NEEDLE BROKE IN THE TISSUE DURING THE PROCEDURE. IMAGING CONFIRMED THAT A NEEDLE REMNANT WAS RETAINED IN THE TISSUE, AND ATTEMPTS WERE MADE TO RETRIEVE THE RETAINED FRAGMENT BOTH LAPAROSCOPICALLY AND VAGINALLY HOWEVER, THE FRAGMENT COULD NOT BE RECOVERED, AND THE DECISION WAS MADE TO CLOSE THE PROCEDURE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 24554541 ↗
• MalfunctionMar 4, 2026

  LAPAROSCOPIC HYSTERECTOMY UNCOMPLICATED UNTIL CLOSURE- THE VAGINAL CUFF WAS CLOSED WITH ENDOSTITCH DEVICE AND WHEN BACK SUTURE TO LOCK THE SUTURE IN PLACE OCCURRED THE NEEDLE WHEN TOGGLED WAS EMBEDDED IN TISSUE AND DISLODGED FROM THE ENDOSTITCH DEVICE- UPON REMOVAL SUTURE BROKE OFF OF THE NEEDLE WHICH REMAINED RETAINED IN CUFF- MULTIPLE ATTEMPTS COMPLETED TO REMOVE NEEDLE VAGINALLY AND LAPAROSCOPICALLY- C- ARM FLUOROSCOPY PERFORMED SHOWING THE NEEDLE IN SITU LEFT BY PUBIC RAMI WHERE CONCERN NEEDLE IN VAGINAL CUFF NOTED. UNABLE TO BE PALPATED OR LOCATED IN RESECTED TISSUE. MAGNET USED TO TRY AND LOCATE IN TISSUE LAPAROSCOPICALLY AND VAGINALLY AND UNABLE TO BE FOUND. TISSUE RESECTED BUT GIVEN CLOSE TO BLADDER EDGE AND NEARING VASCULAR PEDICLE DECISION WAS MADE TO ABANDON REMOVAL AND CUFF WAS CLOSED VAGINALLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24505589 ↗
• MalfunctionMar 3, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, DURING THE CLOSING OF THE MESENTERY, THE NEEDLE DISENGAGED AND FELL INTO THE CAVITY. THE RELOAD WAS REPLACED, BUT THE SAME ISSUE OCCURRED. THE NEEDLE WAS RETRIEVED BY USING GRASPERS. A NEW ENDOSTITCH INSTRUMENT AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499805 ↗
• MalfunctionFeb 25, 2026Difficult to Open or Close; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A THORACIC LAPAROSCOPIC PROCEDURE, THE JAWS OF THE DEVICE WOULD NOT OPEN AND WERE STUCK TOGETHER, AND THE NEEDLE REMAINED IN THE JAWS OF THE DEVICE. ANOTHER DEVICE WAS USED 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 24449196 ↗
• InjuryFeb 17, 2026Detachment 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 CATHETER 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24361633 ↗

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