Signia SIGPHANDLERecalls & reported problems
Covidien LP · Power Handle · Class 2
All models of Signia (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Signia power handle is the powered handle of a surgical stapler. The reports often describe the handle losing power, failing to charge, and staples failing to fire or misfiring. FDA records list 5,351 reports, 3 deaths, 239 injuries and 5,109 malfunctions. There is 1 closed recall, which began in December 2017 and concerned the product shutting down during use. Reports fell from 482 in the prior 12 months to 200 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 5,356
- Deaths reported
- 3
- Injuries reported
- 239
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5,356 adverse event reports that list this exact device (DI 10884521543782), received between Apr 28, 2017 and Sep 29, 2026 — classified as 3 deaths, 239 injuries, 5,114 malfunctions.
The most frequently reported specific device problem is “Complete Loss of Power” (1,566 reports).
1 FDA recall record name this device's identifier.
13 other recalls cover devices cleared under the same FDA submission (K160176, K201672, K240881); 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 18, 2026.
Reports received per month
Recalls naming this device
- Dec 13, 2017Class IITerminated
Product reportedly shutting down during use.
Z-1237-2018 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Complete Loss of Power1,566
- Failure to Charge1,291
- Misfire903
- Device Displays Incorrect Message716
- Failure to Fire578
- Difficult to Open or Close544
- Power Problem518
- Entrapment of Device476
Patient problems
- No Clinical Signs, Symptoms or Conditions3,322
- No Consequences Or Impact To Patient557
- No Patient Involvement514
- No Known Impact Or Consequence To Patient377
- Insufficient Information281
- Tissue Breakdown186
- Unspecified Tissue Injury135
- No Code Available116
Recent adverse event reports
The 25 most recent of 5,356 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937104 ↗MalfunctionSep 29, 2026Misfire
According to the reporter, during a low anterior resection, at the time of rectal resection, partial firing occurred. Firing stopped at 1 cm site. The reload was replaced to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929215 ↗MalfunctionSep 28, 2026Battery Problem; Complete Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924261 ↗MalfunctionSep 24, 2026Misfire
It was reported that during a gastric bypass procedure, the surgeon positioned the stapler on the tissue to create the gastric pouch. Upon the third firing, after noting that the indicator read "1", the surgeon began to fire, but midway through the firing, the tissue began to bunch up, the staples started to deform, and the blade failed to advance. The issue was managed by resecting and re-stapling the tissue.
Patient problems: Tissue Breakdown
MAUDE report 50877012 ↗MalfunctionSep 23, 2026Misfire
It was reported that during an open colon resection, partial firing had occurred. The firing stopped once staples reached the tissue. The power handle was replaced after the multiple failed reloads. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863659 ↗MalfunctionSep 22, 2026Device Slipped; Device Displays Incorrect Message
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860365 ↗MalfunctionSep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that during an open colostomy reversal procedure at the anastomosis, the device was involved in a product issue reported as unknown for the handle. Surgical time was extended, and an anastomosis issue required resection and re-stapling at the anastomosis site with creation of a second anastomosis. A shorter colon length was reported.
Patient problems: Failure to Anastomose
MAUDE report 50854490 ↗MalfunctionSep 22, 2026Failure to Fire
According to the reporter, intra-operatively, the reload did not fire. Another reload was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850149 ↗MalfunctionSep 22, 2026Difficult to Open or Close
According to the reporter, during a robotic sigmoidectomy for sigmoid resection, and after firing, the reload could not be removed because the jaw would not open, despite the display indicating the device was active and ready, the tissue appeared to be caught at the cartridge tip, interfering with opening and closing, and the cartridge detached while being handled by the nurse. The reporter stated that the firing into tissue was completed without issue and staple formation appeared normal. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850010 ↗MalfunctionSep 21, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847561 ↗MalfunctionSep 21, 2026Entrapment of Device; Retraction Problem
Patient problems: Tissue Breakdown
MAUDE report 50847090 ↗MalfunctionSep 21, 2026Misfire
According to the reporter, during a procedure, the screen displayed that the powered handle was not firing properly. A new powered handle was used to resolve the issue. There was no patient injury.
Patient problems: Insufficient Information
MAUDE report 50835136 ↗MalfunctionSep 15, 2026Entrapment of Device; Retraction Problem; Device Displays Incorrect Message
Patient problems: Tissue Breakdown
MAUDE report 50780928 ↗MalfunctionSep 3, 2026Computer Software Problem; Device Displays Incorrect Message
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50596305 ↗MalfunctionSep 2, 2026Computer Software Problem; Device Displays Incorrect Message
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572596 ↗MalfunctionAug 27, 2026Failure to Cut
According to the reporter, during a gastrectomy, the device was fired and the tissue was not resected by the knife, and staples were scattered. To resolve the issue, a manual handle and a new cartridge were used. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50481881 ↗MalfunctionAug 25, 2026Product Quality Problem; Complete Loss of Power
According to the reporter, prior to use, after being fully charger, the powered handle got wet and submerged, and it did not turn on. There was no patient involved. Medtronic's initial evaluation of the incident is that the handle was received with a fully depleted battery. One of the battery cells was found to be vented.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50437810 ↗MalfunctionAug 24, 2026Failure to Charge; Failure to Power Up; Complete Loss of Power
Patient problems: Insufficient Information
MAUDE report 50419045 ↗MalfunctionAug 14, 2026No Display/Image; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256264 ↗MalfunctionAug 14, 2026Computer Software Problem; Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253072 ↗MalfunctionAug 14, 2026Entrapment of Device; Misfire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251339 ↗MalfunctionAug 13, 2026Unintended System Motion; Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237534 ↗MalfunctionAug 12, 2026Misfire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50219877 ↗MalfunctionAug 12, 2026Entrapment of Device
Patient problems: Tissue Breakdown
MAUDE report 50219750 ↗MalfunctionAug 11, 2026Failure to Power Up; Complete Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210530 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K160176, K201672, K240881. One submission often covers many models, so check the product and lot details in each record.
- Z-1228-2023 · Jan 25, 2023 · Open, ClassifiedTri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
- Z-1829-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
- Z-1835-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
- Z-1834-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
- Z-1832-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
- Z-1825-2019 · May 17, 2019 · Open, ClassifiedEGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
- Z-1828-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
- Z-1833-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
- Z-1830-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
- Z-1831-2019 · May 17, 2019 · Open, ClassifiedEGIA45 CT AR MD THK REL, EGIA45CTAMT
- Z-1827-2019 · May 17, 2019 · Open, ClassifiedEGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
- Z-1826-2019 · May 17, 2019 · Open, ClassifiedEGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
- Z-1836-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
Other STAPLE, IMPLANTABLE devices
- Endo GIA EGIA60AMTCovidien LP · STAPLE, IMPLANTABLE19 deaths10,680 reports
- Endo GIA Ultra EGIAUSTNDCovidien LP · STAPLE, IMPLANTABLE5 deaths9,730 reports
- ECHELON FLEX PSEE60AEthicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE1 recall13 deaths3,294 reports
- Endo GIA Ultra EGIAUSHORTCovidien LP · STAPLE, IMPLANTABLE2 deaths3,011 reports
- Endo GIA EGIA45AMTCovidien LP · STAPLE, IMPLANTABLE10 deaths2,965 reports
- Endo GIA Ultra EGIAUXLCovidien LP · STAPLE, IMPLANTABLE2,909 reports
- ENDOPATH ATS45Ethicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE2 deaths2,046 reports
- ECHELON FLEX PVE35AEthicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE29 deaths1,880 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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