SURGICOUNT 0632244160Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 37613327512640), received between Oct 25, 2022 and Jul 29, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (7 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Material Frayed

  I was reported that during a robotic abdominal procedure, a 4 x 4 Ray-Tec sponge visibly frayed and the radiopaque marker began to separate from the sponge. Upon removal, multiple fragments of frayed sponge material were found to have detached and remained within the patient¿s abdomen. The procedure was converted to an open abdominal approach due to unrelated intraoperative complications, which allowed the surgical team to irrigate and inspect the abdominal cavity and remove all visible fragments before closure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070606 ↗
• MalfunctionOct 28, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: DELIVERED AS UNSTERILE PRODUCT, 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT, 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399856 ↗
• MalfunctionOct 28, 2025Material Frayed; Material Frayed

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAYED. 1 EVENT HAD INSUFFICIENT INFORMATION.

  Patient problems: Insufficient Information; Laceration(s)

  MAUDE report 23399825 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399786 ↗
• MalfunctionJul 29, 2025Material Frayed; Material Frayed

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAYED. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22648132 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22648106 ↗
• MalfunctionOct 22, 2024Material Frayed; Material Frayed

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE MATERIAL REPORTEDLY FRAYED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504492 ↗
• MalfunctionJul 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823091 ↗
• MalfunctionJul 24, 2024Material Frayed; Material Frayed

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE MATERIAL REPORTEDLY FRAYED. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818490 ↗
• MalfunctionApr 15, 2024Material Frayed; Material Frayed

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE MATERIAL REPORTEDLY FRAYED. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113329 ↗
• MalfunctionApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16801792 ↗
• MalfunctionOct 25, 2022Material Frayed; Material Frayed

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE MATERIAL REPORTEDLY FRAYED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666548 ↗