N/A SDH25ARecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705036003526), received between Dec 20, 2017 and Jun 8, 2023 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (20 reports).

13 other recalls cover devices cleared under the same FDA submission (K983536); 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE, AFTER THE DEVICE WAS FIRED, NOTED THE STAPLES MALFORMED. CHANGED TO THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086071 ↗
• MalfunctionJun 5, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE SURGERY, AFTER THE DEVICE WAS FIRED, NOTED THE STAPLES MALFORMED. CHANGED TO THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067090 ↗
• MalfunctionJun 2, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE DEVICE COULD NOT FIRE. CHANGED TO THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051918 ↗
• MalfunctionDec 19, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE LOW ANTERIOR RESECTION SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008133 ↗
• MalfunctionNov 18, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED. PROCEDURE: UNKNOWN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824872 ↗
• MalfunctionSep 26, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE GASTROJEJUNOSTOMY SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15485028 ↗
• MalfunctionJun 23, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED. PROCEDURE: RIGHT HEMICOLECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787509 ↗
• MalfunctionMay 16, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE RECTUM SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407237 ↗
• MalfunctionFeb 17, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE. CHANGED TO A NEW ONE TO COMPLETE SURGERY (USED SUTURE TO OVERSEW). THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552070 ↗
• MalfunctionJan 20, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13309656 ↗
• MalfunctionDec 13, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE ENDOSCOPIC RADICAL GASTRECTOMY FOR GASTRIC CANCER SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983422 ↗
• MalfunctionOct 5, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING LAPAROSCOPIC COLON SURGERY , WHEN SEVERING COLONIC TISSUE , AFTER FIRED, NOTED SOME STAPLES MALFORMED . CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12578157 ↗
• MalfunctionJun 16, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING RADICAL RESECTION OF LOW RECTAL CANCER SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED . CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009203 ↗
• MalfunctionMay 6, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE RADICAL RESECTION OF RECTAL CANCER SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784855 ↗
• MalfunctionNov 13, 2020Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING THE EMERGENCY GASTRIC SURGERY SURGERY, COULD NOT FIRE WHEN SEVERING GASTROINTESTINAL TISSUE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10837136 ↗
• MalfunctionJun 29, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE ENDOSCOPIC ESOPHAGECTOMY, WHEN SEVERING ESOPHAGEAL AND GASTRIC TISSUES, AFTER FIRED, NOTED SOME STAPLES MALFORMED. USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10206003 ↗
• MalfunctionDec 3, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING THE RADICAL RESECTION OF LOW RECTAL CANCER SURGERY, WHEN SEVERING RECTUM TISSUE, AFTER FIRED, NOTED THE STAPLES MALFORMED WITH IRREGULAR SHAPE AND THE TISSUE WAS OOZING. USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401150 ↗
• MalfunctionSep 6, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING THE RESECTION OF GASTRIC CANCER SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED. CHANGED TO NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8969390 ↗
• MalfunctionJun 21, 2019Failure to Form Staple

  MISSING STAPLES. IT WAS REPORTED THAT DURING THE LAPAROSCOPIC RADICAL RESECTION OF RIGHT COLON CANCER SURGERY, NOTED INCOMPLETE STAPLE LINE, SOME STAPLES WERE MISSING. SUTURE WAS USED TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8723881 ↗
• MalfunctionMay 8, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER FIRED, NOTED THE STAPLES WERE MALFORMED. CHANGED TO A NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8593339 ↗
• MalfunctionApr 19, 2019Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC SURGERY FOR RIGHT COLON CANCER SURGERY, COULD NOT FIRE (COULD NOT PTOP). CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED. AFTER SURGERY, THE CUSTOMER TRIED TO FIRE WITHOUT TISSUE, THE DEVICE COULD PERFORM FIRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532181 ↗
• InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A COLON RESECTION, THERE WAS BLEEDING AFTER SURGERY. DURING THE COLORECTAL SURGERY, AFTER SURGERY, NOTED THE PATIENT WAS BLEEDING. DID THE SECOND SURGERY, USED THE SUTURE TO OVERSEW.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8505712 ↗
• MalfunctionDec 21, 2018Failure to Form Staple

  STAPLES MALFORMED. IT WAS REPORTED THAT DURING THE OPEN ESOPHAGECTOMY, AFTER FIRED, NOTED THE STAPLES MALFORMED WITH OOZING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8190915 ↗
• MalfunctionDec 17, 2018Failure to Form Staple; Failure to Fire

  IT WAS REPORTED: COULD NOT FIRE. DURING THE LAPAROSCOPIC RADICAL RESECTION OF COLON CANCER, COULD NOT SQUEEZE DOWN THE FIRING TRIGGER EVEN WITH BIG FORCE, WITHOUT AUDIBLE FEEDBACK, HALF OF STAPLES WERE MALFORMED. SUTURE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8168850 ↗
• MalfunctionDec 16, 2018Failure to Form Staple; Firing Problem

  IT WAS REPORTED: COULD NOT FIRE. DURING THE LAPAROSCOPIC RADICAL RESECTION OF COLON CANCER, COULD NOT SQUEEZE DOWN THE FIRING TRIGGER EVEN WITH BIG FORCE, WITHOUT AUDIBLE FEEDBACK, THE STAPLES WERE MALFORMED. SUTURE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8167925 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K983536. One submission often covers many models, so check the product and lot details in each record.

• Z-1271-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1275-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1267-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1268-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1276-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1269-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1278-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1270-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1273-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1277-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1274-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1272-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-0672-2018 · Oct 23, 2017 · Terminated
  Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.