Polysorb 170053Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 20884521126739), received between Oct 12, 2016 and Jul 31, 2026 — classified as 26 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (33 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Apr 15, 2026Open, Classified

   The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.

   Z-2281-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100410 ↗
• 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 25682484 ↗
• 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 25682429 ↗
• InjuryAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY; THE NEEDLE BECAME DETACHED FROM THE END OF THE STITCH AND LODGED INTO TISSUE WHILE SUTURING THE VAGINAL CUFF. THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE, AND THE NEEDLE WAS SUBSEQUENTLY REMOVED AND COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22893582 ↗
• InjuryJun 23, 2025Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE SNAPPED, POPPED OFF THE SUTURE ON THE FIRST TOGGLE, RESULTING IN A RETAINED FOREIGN BODY WITHIN THE PATIENT. THE DEVICE WAS DIFFICULT TO TOGGLE. THE SURGICAL TIME WAS EXTENDED BY 1.5 HOURS AS THE SURGICAL TEAM SEARCHED FOR THE LOST NEEDLE PIECE BUT WERE UNABLE TO LOCATE OR RETRIEVE IT. THE PATIENT REQUIRED EXTRA ANESTHESIA DUE TO THE EXTENDED PROCEDURE AND RETAINED THE FOREIGN BODY, RESULTING IN A PERMANENT INJURY. TO COMPLETE THE CASE, A RELOAD WAS USED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22312458 ↗
• InjuryAug 6, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, WHEN THE SURGEON TOOK THEIR FIRST BITE OF THE STOMACH POUCH TO START THE ANASTOMOSIS BETWEEN THE STOMACH AND THE BOWEL, THE NEEDLE BROKE AND HALF OF THE NEEDLE FELL OFF AND WAS LOST IN THE PATIENT'S BODY. THE SURGEON USED AN X-RAY BUT WAS UNABLE TO LOCATE THE BROKEN HALF OF THE NEEDLE. THE PIECE THAT REMAINED INSIDE WAS APPROXIMATELY 5 MILLIMETER IN LENGTH. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19919807 ↗
• InjuryAug 5, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, DURING THE SEWING OF THE GASTROJEJUNUM, THE NEEDLE BROKE IN HALF AND FELL INTO THE PATIENT CAVITY. IT WAS NOTED THAT ONLY A SMALL PORTION OF THE BROKEN NEEDLE WAS FOUND AND RETRIEVED AND THERE IS STILL A PORTION OF THE NEEDLE BROKEN THAT REMAINED ON THE PATIENT. AN X-RAY WAS PERFORMED AND THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THE SAME HANDLE WAS USED WITH THE NEW RELOAD TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19912607 ↗
• InjuryJan 12, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE FROM THE SUTURING DEVICE BROKE WHILE SUTURING AROUND A METAL ORVIL. IT WAS REPORTED THAT THE DEVICE FRAGMENT OF A 9MM NEEDLE IN THE RIGHT CHEST WAS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18507366 ↗
• InjuryDec 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRIC SLEEVE, WHILE IN THE STOMACH, THE NEEDLE OF THE SUTURE FELL INTO THE PATIENT¿S CAVITY. THE NEEDLES WERE ATTEMPTED TO BE RETRIEVED BUT WERE LEFT IN THE PATIENT BECAUSE THEY COULD NOT BE FOUND AND THEY ARE TOO SMALL TO X-RAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18262347 ↗
• InjuryDec 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRIC SLEEVE, WHILE IN THE STOMACH, THE NEEDLE OF THE SUTURE FELL INTO THE PATIENT¿S CAVITY. THE NEEDLES WERE ATTEMPTED TO BE RETRIEVED BUT WERE LEFT IN THE PATIENT BECAUSE THEY COULD NOT BE FOUND AND THEY ARE TOO SMALL TO X-RAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18262210 ↗
• InjuryNov 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ESOPHAGECTOMY, THE SURGEON WAS OVER SEWING AROUND THE ORAL ANVIL. THE SURGEON HIT THE ORAL ANVIL WITH THE NEEDLE AND THAT CAUSE THE NEEDLE TO BREAK IN HALF. THE NEEDLE FELL OFF THE DEVICE INTO THE CAVITY OF THE PATIENT AND WAS NOT FOUND. HALF OF THE NEEDLE REMAINED IN THE PATIENT'S CAVITY. A NEW DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18151612 ↗
• InjurySep 6, 2023Break; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE DEVICE ENCOUNTERED AN ISSUE WHILE BEING APPLIED DURING THE OVERSEWING OF THE STOMACH. THE NEEDLE BECAME CHALLENGING TO PASS THROUGH THE TISSUE ON BOTH THE FIRST AND SECOND "THROW/BITE" OF THE SUTURE HANDLE; THAT WAS WHEN THE NEEDLE BROKE. AS A RESULT, THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THIS PRODUCT PROBLEM. ADDITIONALLY, THE BROKEN NEEDLE FELL INTO THE PATIENT'S CAVITY. AN X-RAY WAS CONDUCTED TO LOCATE THE COMPONENT AND ENSURE ALL PIECES WERE ACCOUNTED FOR. IT WAS DETERMINED TO LEAVE THE BROKEN PORTION OF THE NEEDLE IN THE STOMACH TISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 17691667 ↗
• MalfunctionJul 3, 2023Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHEN SEWING THE GASTROJEJUNAL, AT FIRST PASS AND IT WORKED FINE, ON THE SECOND PASS WHEN GOING THROUGH TISSUE, THE DEVICE WOULD NOT CLOSE DOWN. THE DEVICE WOULD CLOSE OUT OF THE BODY BUT NOT GOING THROUGH TISSUE. THE SUTURE NEEDLE ALSO BROKE IN HALF WHEN TRYING TO CLOSE IT DOWN. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17250369 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THREE TO FOUR DAYS POSTOPERATIVELY OF LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (RYGB) PROCEDURE, AT THE JEJU NOJEJUNOSTOMY ANASTOMOSIS, THERE WAS A BLEEDING THAT CAUSED THE CONSERVATIVE MANAGEMENT. THE PATIENT EXTENDED HOSPITALIZATION FOR 3 DAYS. THE PATIENT WAS BACK TO OPERATIONAL THEATER (OT) AND RE-SUTURING WAS DONE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17050723 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THREE TO FOUR DAYS POSTOPERATIVELY OF LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (RYGB) PROCEDURE, AT THE JEJU NOJEJUNOSTOMY ANASTOMOSIS, THERE WAS A BLEEDING THAT CAUSED THE CONSERVATIVE MANAGEMENT. THE PATIENT EXTENDED HOSPITALIZATION FOR 3 DAYS. THE PATIENT WAS BACK TO OPERATIONAL THEATER (OT) AND RE-SUTURING WAS DONE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17050694 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, THE PATIENT HAD A BLEEDING IN THE SUTURE LINE WHICH RESULTED IN DECREASE OF HEMOGLOBIN. CONSERVATIVE MANAGEMENT VIA BLOOD TRANSFUSION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION AT THE SAME TIME THE PATIENT WAS MONITORED. THERE WAS EXTENDED PATIENT HOSPITALIZATION OF 2 DAYS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17006299 ↗
• InjuryMay 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, DURING THE VAGINAL VAULT SUTURE, THE NEEDLE GOT STUCK IN THE VAGINAL MUSCLE LAYER. IT WAS ALSO MENTIONED THAT THE THREAD AND NEEDLE BROKE IN HALF.

  Patient problems: Foreign Body In Patient

  MAUDE report 16983839 ↗
• InjuryMay 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING HYSTERECTOMY, WHILE USING THE DEVICE, THE NEEDLE CAME OFF AND GOT STUCK IN THE PATIENT¿S TISSUE. THE DEVICE COULD NOT BE SAFELY REMOVED.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 16844210 ↗
• InjuryFeb 13, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, LIGATION, THE NEEDLE BROKE INTO PIECES AND FELL INTO THE PATIENT'S CAVITY AND REMAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16362515 ↗
• InjuryNov 8, 2022Break; 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 A LAPAROSCOPIC HYSTERECTOMY, WHILE CLOSING THE CUFF OF THE VAGINA, THE NEEDLE BROKE OFF AND THEY WERE NOT ABLE TO FIND IT. THE BROKEN PIECE OF NEEDLE FALL INTO THE CAVITY OF PATIENT. THEY HAD TO LEAVE THE BROKEN PIECE OF NEEDLE IN THE PATIENT.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 15754751 ↗
• MalfunctionOct 6, 2022Component or Accessory Incompatibility; Difficult to Open or Close; Human-Device Interface Problem; Component or Accessory Incompatibility; Difficult to Open or Close; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRIC SLEEVE, THERE WAS AN ISSUE WITH LOADING AND UNLOADING OF THE DEVICE. WHILE LOADING THE DEVICE, THE DEVICE LOCKED INTO PLACE AND THE JAWS WOULD NOT OPEN. THE DEVICE WAS EVENTUALLY DISLODGED AND WORKED. THE PROCEDURE WAS COMPLETED USING A NEW LOADING UNIT WITH THE SAME HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551483 ↗
• InjuryJun 16, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. THE PORTION OF THE BROKEN NEEDLE WAS NOT FOUND AND WAS NOT RETRIEVED. A NEW SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14716003 ↗
• InjuryJun 15, 2022Entrapment of Device; Use of Device Problem; Entrapment of Device; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC ROUX-EN-Y GASTRIC BYPASS, DURING THE OVERSEWING OF THE GASTROJEJUNOSTOMY ANASTOMOSIS, ON THE FIRST RELOAD, THE NEEDLE OF THE ENDO STITCH SUTURE BECAME STUCK IN THE RECEIVING END JAWS OF THE HANDLE AND WAS CAUGHT WITH THE TISSUE. THE NEEDLE DID NOT PENETRATE THE TISSUE COMPLETELY, BUT BOTH THE NEEDLE AND TISSUE WERE BEING HELD IN THE RECEIVING END OF THE JAWS. THE JAWS WERE ABLE TO OPEN COMPLETELY.  THE METAL BARS ON THE JAWS WAS NOT PRESENT. THE SURGEONS HAD TO TWIST, TURN AND TUG AT THE RELOAD BEFORE IT WOULD COME AWAY FROM THE TISSUE. THE SECOND SUTURE THAT WAS USED GOT STUCK ALSO. THE ATTENDING SURGEON, WAS ABLE TO FREE THE NEEDLE FROM THE STOMACH TISSUE AND COMPLETED THE OVERSEWING WITHOUT ISSUE. IT WAS NOTED THAT THE PATIENT HAD SOME SEROSAL TEARING DUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14698658 ↗
• MalfunctionJun 6, 2022Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN THE SCRUB STAFF LOADED THE DEVICE, IT WAS TOGGLED BACK AND FORTH BEFORE HANDING IT TO THE SURGEON BUT THE NEEDLE BROKE. SOME PART OF THE NEEDLE WAS STILL ON THE DEVICE. ON THE SECOND HANDLE, AFTER LOADING, THE DEVICE WOULD ONLY TOGGLE ONE DIRECTION, NOT THE OTHER DIRECTION. IT WAS ALSO NOTED THAT THE TWO DEVICES WERE DIFFICULT TO UNLOAD. THE DEVICES WAS NOT USED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14602691 ↗
• MalfunctionMar 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS, WHEN THE SURGEON WENT TO FINISH THE ANASTOMOSIS, THE SUTURE THREAD DETACHED FROM THE NEEDLE. THE SAME ISSUE OCCURRED ON TWO UNITS WHEN THE SURGEON WAS PULLING THE STITCH THROUGH. THE SUTURE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED USING A GRASPER. THE SURGEON HAD TO TAKE THE WHOLE STITCH OUT AND START OVER EACH TIME. ANOTHER RELOAD WITH THE SAME HANDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590466 ↗

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-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