N/A CDH25ARecalls & reported problems

Summary

The FDA's MAUDE database contains 939 adverse event reports that list this exact device (DI 10705036003458), received between Dec 1, 2017 and Sep 30, 2026 — classified as 7 deaths, 104 injuries, 828 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (442 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 939 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948323 ↗
• MalfunctionSep 23, 2026Failure to Cut

  It was reported that during an Unknown procedure the circular stapler misfired during the procedure.Was there any reported patient or user harm? No. Was there a significant delay? No.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867272 ↗
• MalfunctionSep 21, 2026Failure to Fire

  It was reported that during and Unknown procedure, 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 50839246 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50571825 ↗
• MalfunctionAug 31, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520837 ↗
• MalfunctionAug 25, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50429216 ↗
• MalfunctionAug 18, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that during an Unknown surgery. After installed the reload and removed the retaining cap, the surgeon noted that some staples protruding. 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 50300031 ↗
• MalfunctionJun 18, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE RECTUM PROCEDURE 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 25552440 ↗
• MalfunctionJun 18, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK 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 25547846 ↗
• MalfunctionJun 16, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK 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 25521713 ↗
• MalfunctionMay 27, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK 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 25302153 ↗
• MalfunctionMay 26, 2026Failure to Fire

  IT WAS REPORTED THAT DURING PROCTRECTOMY PROCEDURE, 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 25283807 ↗
• MalfunctionMay 23, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK 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 25264560 ↗
• MalfunctionMay 14, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE ESOPHAGEAL 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 25173984 ↗
• MalfunctionMay 13, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED AND OOZING OCCURRED. SUTURE WAS USED TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

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

  MAUDE report 25165086 ↗
• MalfunctionMay 7, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING PROCTRECTOMY PROCEDURE AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 25117885 ↗
• MalfunctionMay 4, 2026Ejection Problem

  IT WAS REPORTED THAT BEFORE THE UNK SURGERY, OPEN THE PACKING AND NOTED ANVIL CANNOT BE ATTACHED. 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 25072148 ↗
• MalfunctionApr 30, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE UNK SURGERY. AFTER FIRED, NOTED THAT A FEW STAPLES FORMED WITH IRREGULAR SHAPES AND ANASTOMOTIC SITE WAS OOZING. SUTURE WAS USED TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED, NO ADDITIONAL INFORMATION COULD BE PROVIDED.

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

  MAUDE report 25048585 ↗
• InjuryApr 23, 2026Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LE Z, ZHANG Z, ZHOU T, LIU M. ESOPHAGOJEJUNAL ANASTOMOSIS AFTER TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY: ¿-SHAPED VERSUS REVERSE PUNCTURE DEVICE ANASTOMOSIS. ANN ITAL CHIR. 2025 OCT 10;96(10):1400-1408. DOI: 10.62713/AIC.4221. PMID: 41099107. THIS STUDY AIMED TO COMPARE THE ADVANTAGES OF -SHAPED ANASTOMOSIS WITH REVERSE PUNCTURE DEVICE (RPD) ANASTOMOSIS FOLLOWING TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY (TLTG). BETWEEN 1 JANUARY 2020 AND 1 JANUARY 2024, A TOTAL OF 133 PATIENTS WITH GASTRIC CANCER WHO UNDERWENT TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY (TLTG). PATIENTS WERE CATEGORIZED INTO A -SHAPED GROUP (67 PATIENTS) AND AN RPD GROUP (66 PATIENTS) ACCORDING TO THE ESOPHAGOJEJUNAL ANASTOMOSIS METHOD. THERE WERE 38 (57%) MALES AND 29 (43%) FEMALES IN THE -SHAPED GROUP WITH THE MEAN AGE OF 64.9 ± 8.9 YEARS OLD WHILE THERE WERE 39 (59%) MALES AND 27 (41%) FEMALES IN THE RPD GROUP WITH THE MEAN AGE OF 66.3 ± 7.3 YEARS OLD. A PURSE-STRING SUTURE WAS SECURED BY APPLYING TRACTION TO THE SUTURES PREFIXED ON THE ANVIL, AND THE STUMP OF THE ESOPHAGUS WAS CLOSED WITH A 60-MM ETHICON LINEAR STAPLER (FIG. 1C

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Obstruction/Occlusion

  MAUDE report 24966092 ↗
• MalfunctionApr 11, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE PROCTECTOMY 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 24852638 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TSUJIMURA K, NAKAUCHI M, HIRO J, ITO A, CHIKAISHI Y, KOBAYASHI Y, KAMISHIMA M, INAGUMA G, OMURA Y, CHEONG Y, KUMAMOTO T, MASUMORI K, HANAI T, UYAMA I, SUDA K, OTSUKA K. COMPARISON OF SHORT-TERM OUTCOMES FOR ROBOTIC RECTAL SURGERY BETWEEN THE HINOTORI¿ SURGICAL ROBOT SYSTEM AND DA VINCI SURGICAL SYSTEM: A SINGLE-CENTER RETROSPECTIVE STUDY USING PROPENSITY SCORE MATCHING ANALYSIS. SURG ENDOSC. 2025 JUN;39(6):3993-4005. DOI: 10.1007/S00464-025-11766-6. EPUB 2025 MAY 2. PMID: 40316750. THE AIM OF THIS STUDY IS TO REPORT OUR INITIAL SURGICAL EXPERIENCES WITH ROBOTIC SURGERY USING HINOTORI FOR RECTAL CANCER AND ITS FEASIBILITY AND SAFETY COMPARING WITH DA VINCI. BETWEEN NOVEMBER 2022 AND NOVEMBER 2023, A TOTAL OF 38 AND 96 PATIENTS WITH RECTAL CANCER UNDERWENT ROBOTIC SURGERY USING HINOTORI AND DA VINCI, RESPECTIVELY. THE MEDIAN AGE WAS 69.5 YEARS IN THE HINOTORI GROUP AND 69 YEARS IN THE DA VINCI GROUP. MORE THAN HALF OF PATIENTS WERE MALE (HINOTORI: 57.9% DA VINCI: 60.5%). IN HINOTORI THE ETHICON DEVICE WAS USED IN: AFTER COMPLETION OF MOBILIZATION OF THE RECTUM AND ITS DEVASCULARIZATION, IF NE

  Patient problems: Failure to Anastomose; Obstruction/Occlusion

  MAUDE report 24835774 ↗
• MalfunctionApr 8, 2026Failure to Cut

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN USING A STAPLER TO PERFORM ANASTOMOSIS, THE STAPLER CANNOT COMPLETELY CUT THROUGH THE TISSUE. NO ADDITIONAL INFORMATION CAN BE PROVIDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818883 ↗
• MalfunctionApr 2, 2026Ejection Problem

  IT WAS REPORTED THAT DURING A LAP GASTRECTOMY THE SPRING AT THE BASE OF STAPLER SPRING OPEN, WHICH CANNOT BE DOCKED WITH THE STAPLER HEAD. CHANGED THE NEW ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769420 ↗
• MalfunctionApr 2, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE RECTUM PROCEDURE, 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 24769063 ↗
• MalfunctionMar 30, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE ESOPHGEAL - GASTRIC ANASTOMOSIS SURGERY, THE FIRE WAS NOT COMPLETED AND THE DEVICE COULD NOT BE REMOVED. AN ELECTROTOME WAS USED TO CUTOFF THE TISSUE AND REMOVE THE DEVICE. FINALLY, SUTURE WAS USED TO SEW THE WOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717145 ↗

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