Purstring 020730Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10884521051478), received between Sep 15, 2017 and Sep 15, 2026 — classified as 2 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Misfire

  It was reported that during the procedure, the purstring stapler failed during use. The device was replaced with a new product. No consequences or impact to the patient were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766611 ↗
• MalfunctionFeb 16, 2026Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE EXPERIENCED FIRING ISSUES. THE DEVICE WAS REPLACED WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349214 ↗
• MalfunctionJun 18, 2025Material Frayed; Misfire; Material Deformation; Material Frayed; Misfire; Material Deformation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A PROBLEM WITH THE FIRING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283440 ↗
• MalfunctionNov 12, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A RADICAL TOTAL GASTRECTOMY, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662222 ↗
• MalfunctionJul 22, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE. TO RESOLVE THE ISSUE, ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791207 ↗
• MalfunctionMar 25, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY COLON RESECTION PROCEDURE, THE SUTURE ON ONE SIDE WAS DISCONNECTED BEFORE FIRING THE DEVICE. SO WHEN THE TISSUE WAS CUT OFF AFTER THE NEEDLE WAS OPERATED, THE SURGEON OPENED THE JAWS AND DISCOVERED THAT THE SUTURE WAS NOT CAUGHT AT THE TISSUE STUMP, IT WAS NOT SECURED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED TO RE- FIRE, AND THE TISSUE WAS REDISSECTED. AFTER THE OPERATION, THE DEVICE WAS DROPPED, AND THE STAPLER PART WAS DAMAGED.

  Patient problems: Tissue Breakdown

  MAUDE report 18969490 ↗
• MalfunctionFeb 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A TOTAL DISTAL GASTRECTOMY FOR GASTRIC CANCER, THE TIP OF THE BLADE FELL OFF WHEN THE DEVICE WAS HELD IN HANDLE AND TRIED TO BE OPERATED AFTER BEING HANDED OVER TO THE PHYSICIAN FROM THE SCRUB NURSE. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790717 ↗
• MalfunctionDec 14, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE DID NOT FIRE. NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18327708 ↗
• MalfunctionSep 18, 2023Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROXIMAL GASTRECTOMY, AT CARDIA RESECTION, THE DEVICE FIRED BUT THE SUTURE DID NOT APPLY. A NEW PURSE STRING DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17763144 ↗
• MalfunctionSep 14, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE DEVICE DID NOT FIRE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746182 ↗
• MalfunctionAug 11, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514515 ↗
• MalfunctionApr 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, IN SETTING THE CIRCULAR STAPLER ANVIL ON THE INTESTINAL TRACT ON THE MOUTH SIDE, THE SUTURE OF THE DEVICE WAS USED. HOWEVER, THE SUTURE HAD FALLEN OFF FROM THE JAWS PART AND COULD NOT BE USED. THE SUTURE DID NOT FALL INTO THE PATIENT'S CAVITY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824993 ↗
• MalfunctionOct 31, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE DID NOT FIRE. THE DEVICE DID NOT WORK AT ALL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15704805 ↗
• MalfunctionOct 19, 2022Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY TOTAL ABDOMINAL GASTRECTOMY, WHEN THE SUTURE WAS PLACED IN THE LUMEN AT THE SAME TIME AS THE NEEDLE STRIKE, THE SUTURE REMAINED IN THE DEVICE. THE THREAD WAS NOT PLACED IN THE INTESTINAL TRACT. TO RESOLVE THE ISSUE, THE SURGEON SEWN BY HAND. IT WAS NOTED THAT THERE WAS NO ADDITIONAL RESECTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633915 ↗
• MalfunctionOct 14, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607268 ↗
• MalfunctionJul 14, 2022Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC HERNIA PROCEDURE, THE THREAD WAS UNTIED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15013925 ↗
• InjuryJul 1, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC OESOPHAGECTOMY, WHILE USING THE DEVICE, THE THREAD BROKE WHEN THE SURGEON TRIED TO MAKE A STITCH. THE PATIENT EXPERIENCED UNANTICIPATED TISSUE LOSS AS A RESULT OF THE EVENT. THE SURGEON TAKES ANOTHER DEVICE WITH THE SAME PRODUCT ID.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14888047 ↗
• MalfunctionApr 13, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE STAPLER DID NOT WORK. THERE WAS NO CUT AND THE STAPLER DID NOT FIRE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104507 ↗
• MalfunctionMar 28, 2022Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE THREAD WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929335 ↗
• MalfunctionMar 8, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693840 ↗
• MalfunctionDec 1, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA SURGERY, THE DEVICE COULD NOT SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910435 ↗
• MalfunctionSep 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN GASTRECTOMY, A DEVICE COMPONENT WAS DISENGAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12547597 ↗
• MalfunctionSep 29, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER INTRAOPERATIVELY, THE DEVICE DID NOT FIRE.

  Patient problems: Insufficient Information

  MAUDE report 12546387 ↗
• MalfunctionSep 16, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL SIGMOIDECTOMY, AFTER SETTING THE PURSE STRING SUTURE AT THE SIGMOID ANASTOMOTIC TISSUE, IT WAS ATTEMPTED TO PERFORM LIGATION, HOWEVER, THE THREAD BROKE WITH LESS FORCE THAN USUAL. IT WAS NOTED THE SUTURE DID NOT GET CAUGHT ON THE DEVICE. THE PURSE STRING SUTURE WAS PERFORMED BY HAND SEWING TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484662 ↗
• MalfunctionAug 9, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293622 ↗