GIA GIA6048SRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884523007244), received between Dec 8, 2017 and Jan 29, 2025 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (5 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825, K221013); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Misfire; Failure to Cut; Misfire; Failure to Cut

  ACCORDING TO THE REPORTER, DURING AN ESOPHAGECTOMY, THE DEVICE WAS ABLE TO FIRE; HOWEVER, THE DEVICE DID NOT CUT, WHICH LEADS TO RAGGED STAPLES LINE FORMATION. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE; HOWEVER, THE SAME ISSUE OCCURRED. ANOTHER DEVICE FROM A COMPETITOR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265577 ↗
• MalfunctionAug 15, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY, THE THREE PRE-LOADED OPEN STAPLER AND THREE ADDITIONAL RELOADS WERE STICKING IN THE SAME PLACE WHEN SLIDING THE PUSHER THUMB PIECE. THE SURGEON RECONSTRUCTED THE FAULT ON A CLEAN DEVICE, AND THE ISSUE WAS RESOLVED IN A FEW MINUTES BY OPENING A NEW DEVICE SO THE OPERATION WAS NOT DELAYED. THE SURGERY WAS COMPLETED BUT MULTIPLE DEVICES WERE NEEDED TO COMPLETE THE ANASTOMOSIS OF THE BOWEL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990732 ↗
• MalfunctionOct 13, 2023Component or Accessory Incompatibility; Detachment of Device or Device Component; Component or Accessory Incompatibility; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE WAS DIFFICULT TO LOAD. THE DEVICE ULTIMATELY UNLOADED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17932929 ↗
• MalfunctionJan 5, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE DID NOT FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102988 ↗
• MalfunctionAug 17, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRAOPERATIVE THE DEVICE WAS UNABLE TO FIRE.

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

  MAUDE report 15241668 ↗
• MalfunctionJul 5, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14916215 ↗
• MalfunctionJun 7, 2022Failure to Align; Component or Accessory Incompatibility; Failure to Align; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING AN OPEN THORACIC WEDGE RESECTION, THE STAPLER COULD NOT BE LOADED WITH THE LOADING UNIT. THE TWO HALVES COULD NOT BE IN PLACE AND NOT LOCKED IN ORDER TO FIRE. ANOTHER HANDLE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14625901 ↗
• InjuryMay 5, 2022Component Missing; Mechanics Altered; Component Missing; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING OPEN LOBECTOMY, WHEN RESECTING LUNG, THE DEVICE WAS FIRED KNIFE WENT THROUGH BUT THERE WERE NO STAPLES. THE SURGEON MANUALLY SUTURED THE RESECTED LUNG.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 14288105 ↗
• InjuryDec 17, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLES DID NOT DEPLOY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13025829 ↗
• MalfunctionNov 16, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE STAPLE DID NOT COME OUT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821300 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ONE DAY POST-OPERATIVELY ON AN EXPLORATORY LAPAROSCOPY SURGERY, THE PATIENT HAD FISTULA. THE PATIENT WAS RE-OPERATED TO RESOLVE THE ISSUE.

  Patient problems: Fistula; No Code Available

  MAUDE report 10104054 ↗
• MalfunctionSep 4, 2019Failure to Fire; Component or Accessory Incompatibility; Failure to Fire; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER PRIOR TO A PROCEDURE, DURING THE TESTING OF THE DEVICE, THE DEVICE DID NOT LAUNCH AND THE RELOAD HAD A SATING ERROR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8960186 ↗
• MalfunctionJan 21, 2019Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER BROKE. THE PATIENT WAS NOT AFFECTED BY THE STAPLER BREAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8265433 ↗
• MalfunctionApr 10, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN WEDGE RESECTION, WHILE RESECTING THE PART OF A LUNG, THE STAPLER DID NOT FIRE AT ALL, THE PUSHER THUMB DIDN'T MAKE ANY MOVE. THE OPERATOR DECIDED TO TAKE ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7419634 ↗
• MalfunctionDec 11, 2017Detachment Of Device Component; Appropriate Device Problem Term/Code Not Available; Detachment Of Device Component; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, A DEVICE HAD BUTTON FIRE DECOUPLING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7104407 ↗
• InjuryDec 8, 2017Failure to Form Staple; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ANASTOMOSIS OF THE DUODENUM OPEN PROCEDURE, THEY LOADED THE STAPLER AND WHEN THE SURGEON TRIED TO CLOSE THE TISSUE WITH STAPLER, THE TISSUE MOVED FROM TWO HALVES OF STAPLER. ALSO LOADING WAS NOT FIXED WELL ENOUGH IN PLACE WHERE IT SHOULD BE FIXED IN THE STAPLER. THIS LED TO AN INCOMPLETE STAPLE LINE AND THEY HAD TO RESECT AND RE-STAPLE. ALSO FOUND THE SINGLE USE STAPLER WAS DIFFICULT OR UNABLE TO CLOSE ON TISSUE BUT WAS ULTIMATELY ABLE TO CLOSE. A STAPLER OF ANOTHER MANUFACTURER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT INCURRED A DUODENUM FISTULA TEMPORARY INJURY.

  Patient problems: Fistula

  MAUDE report 7102545 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111825, K221013. One submission often covers many models, so check the product and lot details in each record.

• Z-0748-2021 · Nov 23, 2020 · Completed
  Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection
• Z-0747-2021 · Nov 23, 2020 · Completed
  Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or tr
• Z-0008-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0003-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0001-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gyn
• Z-0009-2021 · Aug 12, 2020 · Open, Classified
  Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applicat
• Z-0006-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0002-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0005-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric
• Z-0007-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic
• Z-0004-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-1264-2020 · Jan 17, 2020 · Terminated
  Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT

…and 58 more.