Purstring 020242Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10884521051430), received between Jul 28, 2017 and Apr 7, 2026 — classified as 5 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC LOW ANTERIOR RESECTION, DURING ANASTOMOSIS, THE ANVIL AND RELOAD OF THE CIRCULAR STAPLER WERE FULLY CONNECTED BUT THERE WERE HOLES IN THE STAPLE LINE. THE SECOND DEVICE WAS FIRED AND THERE WAS A STAPLE LINE BLEEDING. THE SURGEON RESECTED AND RESTAPLED THE ANASTOMOSIS TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24799099 ↗
• MalfunctionMar 4, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, AT THE BEGINNING, THE DEVICE DID NOT FIRE. THE DEVICE WAS REPLACED 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 24508242 ↗
• MalfunctionDec 11, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE COLECTOMY, THE STAPLES WENT THROUGH TISSUE BUT NEVER FORMED. ANOTHER PURSE STRING DEVICE WAS OPENED AND USED SUCCESSFULLY.

  Patient problems: Tissue Breakdown

  MAUDE report 23783164 ↗
• MalfunctionOct 31, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PURSE STRING WOULD NOT CLOSE DURING USE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23441979 ↗
• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ANTERIOR RESECTION PROCEDURE, WHILE ON THE PURSTRING OF THE COLON, AFTER FIRING THE DEVICE, A SUTURE BREAK OCCURRED. THE SURGEON RESOLVED THE ISSUE BY REPLACING THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063024 ↗
• MalfunctionJul 9, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE ANASTOMOTIC SITE WAS FIRMLY SQUEEZED/SECURED WITH THE PURSE STRING, BUT PART OF THE SUTURE WAS NOT CAUGHT, AND THERE WAS ENOUGH SPACE TO FIT A FORCEPS IN. ADDITIONAL SUTURE WAS PERFORMED BY HAND SEWING.

  Patient problems: Failure to Anastomose

  MAUDE report 22465571 ↗
• MalfunctionJun 23, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A SIGMOIDECTOMY PROCEDURE, THE INSTRUMENT DID NOT FIRE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE AND USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312375 ↗
• MalfunctionJun 20, 2025Misfire; Failure to Fire; Misfire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE HAD FAULTY FIRING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298586 ↗
• MalfunctionApr 30, 2025Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, SUTURE WAS BROKEN IN PURSE STRING DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933044 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT THE SUTURE WAS BROKEN BEFORE BEING USED. THE PROBLEM WAS RESOLVED BY REPLACING THE DEVICE WITH ANOTHER DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 21901387 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO USE, THE PURSESTRING BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883152 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A TRANSIT RECONSTRUCTION PROCEDURE, THE SUTURE BROKE AFTER FIRING. SUTURING WAS DONE AS A STAPLE LINE RE PLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447150 ↗
• MalfunctionJan 24, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE DEVICE, THE INSTRUMENT DID NOT FIRE. THE SAME ISSUE OCCURRED WITH THE SECOND DEVICE. THE DEVICE WAS REPLACED WITH A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 21228999 ↗
• MalfunctionJan 24, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE DEVICE, THE INSTRUMENT DID NOT FIRE. THE SAME ISSUE OCCURRED WITH THE SECOND DEVICE. THE DEVICE WAS REPLACED WITH A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 21228979 ↗
• MalfunctionJan 23, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO USE THE 020242 DISP PURSE STRING 65 X3 DEVICE EXPERIENCED A BREAKAGE, INCLUDING THE STRING/SUTURE. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218163 ↗
• MalfunctionJan 23, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO USE THE 020242 DISP PURSE STRING 65 X3 DEVICE EXPERIENCED A BREAKAGE, INCLUDING THE STRING/SUTURE. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218090 ↗
• MalfunctionNov 1, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SUTURE HANG UP. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586803 ↗
• MalfunctionOct 30, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE OF THE PURSE-STRING DEVICE, HANG UP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570751 ↗
• MalfunctionOct 30, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE HANG UP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569376 ↗
• MalfunctionOct 16, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RESECTION OF MALIGNANT TUMOR OF THE SIGMOID COLON, THE HANDLE WAS SQUEEZED, THE JAWS WERE CLOSED, THE HANDLE LOCK WAS ENGAGED, AND THE FIRING OPERATION WAS PERFORMED. HOWEVER AFTER RESECTING THE TISSUE ALONG THE JAWS WITH A SCALPEL, AND OPENING THE JAWS, THE STAPLE DID NOT ENGAGE ON THE TISSUE, AND IT WAS NOT POSSIBLE TO PERFORM THE PURSE-STRING SUTURE WITH THE PRODUCT'S SUTURE. A SECOND DEVICE WAS USED AND ANOTHER TISSUE RESECTION WAS PERFORMED HOWEVER THE SAME ISSUE OCCURRED. THE SURGEON HAND SEW THE COLON PURSE STRING TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 20465001 ↗
• MalfunctionOct 16, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RESECTION OF MALIGNANT TUMOR OF THE SIGMOID COLON, THE HANDLE WAS SQUEEZED, THE JAWS WERE CLOSED, THE HANDLE LOCK WAS ENGAGED, AND THE FIRING OPERATION WAS PERFORMED. HOWEVER AFTER RESECTING THE TISSUE ALONG THE JAWS WITH A SCALPEL, AND OPENING THE JAWS, THE STAPLE DID NOT ENGAGE ON THE TISSUE, AND IT WAS NOT POSSIBLE TO PERFORM THE PURSE-STRING SUTURE WITH THE PRODUCT'S SUTURE. A SECOND DEVICE WAS USED AND ANOTHER TISSUE RESECTION WAS PERFORMED HOWEVER THE SAME ISSUE OCCURRED. THE SURGEON HAND SEW THE COLON PURSE STRING TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 20462448 ↗
• MalfunctionOct 11, 2024Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURES BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433140 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A SUBTOTAL COLECTOMY, AFTER USING THE PURSE STRING SUTURE DEVICE FOR PROXIMAL SECTION OF THE COLON, THE CIRCULAR STAPLER WAS THE INSERTED AND FIRED. BEFORE REMOVING THE STAPLER, THE ANASTOMOSIS WAS INSPECTED AND A HOLE WAS FOUND IN THE PROXIMAL END. UPON CHECKING THE 'DONUTS', THE DISTAL DONUT WAS COMPLETE, THE PROXIMAL DONUT WITH THE PURSE STRING SUTURE WAS NOT COMPLETE WHERE THE HOLE HAD APPEARED. THE DOCTOR THEN SUTURED THE HOLE IN THE ANASTOMOSIS, THEN GAVE THE PATIENT A TEMPORARY STOMA TO ALLOW THE ANASTOMOSIS TIME TO HEAL. THE SURGICAL TIME WAS EXTENDED BY ONE HOUR DUE TO THE ISSUE.

  Patient problems: Failure to Anastomose; Laceration(s); Tissue Breakdown

  MAUDE report 20359081 ↗
• MalfunctionSep 17, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE HANG UP. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238480 ↗
• MalfunctionAug 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE THREAD WAS BROKEN. 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 19955578 ↗