Signia SIGCIRSTNDRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521845480), received between Mar 19, 2026 and Aug 22, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2026Adverse Event Without Identified Device or Use Problem

  According to a clinical study, on (b)(6)2026, a week following a robotic low anterior resection for a rectal mass involving a powered surgical handle, circular adapter, power shell, and circular reload, the patient presented with abdominal pain, syncope, vomiting, fever, and tachycardia. The patient was found to have an atrial fibrillation with rapid ventricular response, anastomotic leak of the intestine, bowel perforation, and intra-abdominal abscess requiring emergent diagnostic laparoscopy, abscess drainage, laparoscopic partial colectomy, and permanent end colostomy. The event resulted in new inpatient hospitalization from 03-Aug-2026 through 13-Aug-2026. The investigator assessed the event as possibly related to the study procedure and study device. The sponsor assessed a causal relationship to the study procedure and a possible relationship to the study device.

  Patient problems: Abdominal Pain; Abscess; Atrial Fibrillation; Bowel Perforation; Failure to Anastomose; Fever; Syncope/Fainting; Tachycardia; Vomiting

  MAUDE report 50386530 ↗
• MalfunctionAug 5, 2026Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  Patient problems: Tissue Breakdown

  MAUDE report 50137549 ↗
• MalfunctionMar 19, 2026Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED SURGICAL (RAS) SIGMOID COLECTOMY WITH COLOVESICAL FISTULA TAKEDOWN, THE SPIKE WOULD NOT PROPERLY CONNECT TO THE ANVIL AND THE POWERED HANDLE WOULD NOT RECOGNIZE THAT IT WAS CONNECTED TO MEASURE THE ADAPTIVE COMPRESSION TECHNOLOGY. THE SURGEON HAD TO APPLY PRESSURE TO REMOVE THE ANVIL FROM THE SPIKE BUT COULD NOT SUCCESSFULLY PROCEED TO THE NEXT STEP ON THE SCREEN. TO RESOLVE THE ISSUE, A NEW MANUAL CIRCULAR STAPLER WAS USED. IT WAS NOTED THAT THE HANDLE WORK PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636572 ↗