N/A SDH33ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705036003540), received between Feb 4, 2020 and Nov 13, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE RESECTION OF LOW RECTAL CANCER SURGERY, WHEN SEVERING RECTUM AND COLON TISSUE, AFTER FIRED, NOTED STAPLES MALFORMED WITH IRREGULAR SHAPE (WITH STRAIGHT LEG). 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 10838772 ↗
• MalfunctionNov 13, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE RESECTION OF LOW RECTAL CANCER SURGERY, WHEN SEVERING RECTUM AND COLON TISSUE, AFTER FIRED, NOTED STAPLES MALFORMED WITH IRREGULAR SHAPE (WITH STRAIGHT LEG). 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 10838737 ↗
• MalfunctionAug 27, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE OPEN RESECTION OF LOW RECTAL CANCER SURGERY, COULD NOT FIRE WHEN SEVERING RECTAL AND COLON TISSUE. 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 10461405 ↗
• MalfunctionFeb 4, 2020Loose or Intermittent Connection; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING THE OPEN LEFT HEMICOLECTOMY SURGERY, THE CARTRIDGE WAS LOOSE AND STAPLES WERE PROTRUDING. CHANGED TO A NEW ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9667147 ↗

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