N/A SDH29ARecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10705036003533), received between Jan 15, 2018 and Nov 9, 2023 — classified as 1 injury, 33 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (23 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A ESOPHAGUS PROCEDURE, 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 18106807 ↗
• MalfunctionJun 5, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE 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 17065617 ↗
• MalfunctionMar 20, 2023Failure 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: PROCTRECTOMY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576953 ↗
• MalfunctionDec 19, 2022Failure to Form Staple; Failure to Form Staple

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005101 ↗
• MalfunctionDec 16, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE LAP COLON SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE. 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 15997338 ↗
• MalfunctionNov 10, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, AFTER FIRED NOTED THAT THE STAPLES MALFORMED. USED SUTURE TO OVERSEW. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770321 ↗
• MalfunctionNov 4, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE LOW ANTERIOR RESECTION SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15729899 ↗
• MalfunctionOct 17, 2022Ejection Problem; Ejection Problem

  IT WAS REPORTED DURING A LAP GASTRECTOMY THE ANVIL FELL OFF. OPENED THE PACKING, ROTATED THE ADJUSTING KNOB, THE ANVIL FELL OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614788 ↗
• MalfunctionSep 20, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNKNOWN 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 15454181 ↗
• MalfunctionJul 15, 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. PROCEDURE: LAPAROSCOPIC RESECTION OF TRANSVERSE COLON TUMOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15026663 ↗
• MalfunctionJul 11, 2022Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  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: LAP COLON

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981481 ↗
• MalfunctionMay 16, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE LAP COLON SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE. 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 14414046 ↗
• MalfunctionApr 12, 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 14083976 ↗
• MalfunctionNov 11, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN RADICAL RESECTION OF THE RIGHT COLON CANCER SURGERY, AFTER FIRING, IT WAS NOTED THAT SOME STAPLES WERE MALFORMED WITH IRREGULAR SHAPES. USED A 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 12798556 ↗
• MalfunctionAug 11, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING RECTAL CANCER SURGERY, 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 12306684 ↗
• MalfunctionJun 17, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING RADICAL RESECTION OF RIGHT COLON CANCER SURGERY, WHEN SEVERING INTESTINAL TISSUE , 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 12016365 ↗
• MalfunctionJun 15, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, WHEN PERFORMING GASTROINTESTINAL ANASTOMOSIS, AFTER FIRED, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE. THE ANASTOMOSIS SITE BLED. MANUAL ANASTOMOSIS WAS USED AND STOPPED THE BLEEDING. AND THE SURGERY WAS COMPLETED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999694 ↗
• MalfunctionMay 17, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE ENDOSCOPIC 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 11831294 ↗
• MalfunctionJan 16, 2020Failure to Form Staple

  MALFORMED STAPLES. IT WAS REPORTED THAT DURING THE RIGHT COLON SURGERY, AFTER FIRED, THERE WAS NO VOICE FEEDBACK WHEN FIRED TO THE END. IT WAS SEEN THAT THE STAPLE ONLY HALF COMPLETE AND THE OTHER HALF WERE INCOMPLETE. USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9595812 ↗
• MalfunctionNov 25, 2019Failure to Fire

  IT WAS REPORTED THAT DURING A HEMICOLECTOMY, SDH CIRCULAR STAPLER DID NOT FIRE. THE SURGERY WAS DELAYED BY 15-MINUTES. REPLACED WITH A NEW STAPLER TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9371038 ↗
• MalfunctionJul 2, 2019Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SDH29A DIDN¿T COMPLETE FIRE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8752489 ↗
• MalfunctionMay 31, 2019Failure to Form Staple

  MALFORMED STAPLES. IT WAS REPORTED THAT DURING THE THORACIC SURGICAL PROCEDURE 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 Consequences Or Impact To Patient

  MAUDE report 8658856 ↗
• MalfunctionMay 15, 2019Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE RADICAL RESECTION OF ASCENDING COLON CANCER PROCEDURE, THE SURGEON DID NOT SQUEEZE DOWN THE FIRING TRIGGER ONE TIME (NOT IN ONE CONTINUOUS STROKE), AND THE STAPLES FELL OFF. ALL THE STAPLES WERE RETRIEVED FROM THE PATIENT. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8612925 ↗
• MalfunctionMay 13, 2019Nonstandard Device; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LEFT HEMICOLECTOMY SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE. 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 8605868 ↗
• MalfunctionApr 17, 2019Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS FOUND THAT THE STAPLES WERE PROTRUDED WHEN THE PACKAGE WAS OPENED. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522364 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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.