n.a. 021199-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551400227), received between Apr 13, 2026 and Apr 13, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Detachment of Device or Device Component; Output Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE VALVES OF THE TROCARS BROKE DURING THEIR FIRST USE THE HANDLE PRESENTED EXCESSIVE RESISTANCE WHEN OPENING/CLOSING AND WHEN ROTATING THE KNOB, THEY WERE IN THE PROCESS OF PERFORMING SURGERY ON A NEWBORN PATIENT WHEN THE PRODUCTS MENTION FAILED. AS REPORTED PATIENT IS IN THE USUAL CONDITION EXPECTED AFTER SURGERY OF THIS TYPE (THERE IS NO WORSENED CONDITION DUE TO THE EQUIPMENT FAILURE). DURING THE PROCEDURE, THE VALVES OF THE TROCARS BROKE DURING THEIR FIRST USE, APPROXIMATELY HALFWAY THROUGH THE SURGERY. AS A CONSEQUENCE, THE SURGICAL TEAM REPEATEDLY LOST PNEUMOTHORAX, WHICH CAUSED RESPIRATORY COMPLICATIONS AND JEOPARDISED THE CONTINUATION OF THE PROCEDURE. ACCORDING TO THE HOSPITAL, THE INSTRUMENTS INSERTED WERE COMPATIBLE AND WERE HANDLED WITH CARE. IT WAS REPORTED THAT THE MONOPOLAR CABLE SUPPLIED IN THE SAME ORDER DID NOT FUNCTION. THE MEDICAL TEAM CONFIRMED THAT THE ISSUE WAS CAUSED BY THE CABLE ITSELF, AS WHEN REPLACED WITH ANOTHER STORZ CABLE AVAILABLE AT THE HOSPITAL, THE SYSTEM WORKED CORRECTLY. ISSUES WERE IDENTIFIED IN THE HANDLE, WHICH WAS BEING USED FOR THE SECOND TIME. THE CLINICIANS REPORTED THAT THE HANDLE PRESENTED EXCESSIVE RESISTANCE WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853507 ↗
• InjuryApr 13, 2026Detachment of Device or Device Component; Output Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE VALVES OF THE TROCARS BROKE DURING THEIR FIRST USE THE HANDLE PRESENTED EXCESSIVE RESISTANCE WHEN OPENING/CLOSING AND WHEN ROTATING THE KNOB, THEY WERE IN THE PROCESS OF PERFORMING SURGERY ON A NEWBORN PATIENT WHEN THE PRODUCTS MENTION FAILED. AS REPORTED PATIENT IS IN THE USUAL CONDITION EXPECTED AFTER SURGERY OF THIS TYPE (THERE IS NO WORSENED CONDITION DUE TO THE EQUIPMENT FAILURE). DURING THE PROCEDURE, THE VALVES OF THE TROCARS BROKE DURING THEIR FIRST USE, APPROXIMATELY HALFWAY THROUGH THE SURGERY. AS A CONSEQUENCE, THE SURGICAL TEAM REPEATEDLY LOST PNEUMOTHORAX, WHICH CAUSED RESPIRATORY COMPLICATIONS AND JEOPARDISED THE CONTINUATION OF THE PROCEDURE. ACCORDING TO THE HOSPITAL, THE INSTRUMENTS INSERTED WERE COMPATIBLE AND WERE HANDLED WITH CARE. IT WAS REPORTED THAT THE MONOPOLAR CABLE SUPPLIED IN THE SAME ORDER DID NOT FUNCTION. THE MEDICAL TEAM CONFIRMED THAT THE ISSUE WAS CAUSED BY THE CABLE ITSELF, AS WHEN REPLACED WITH ANOTHER STORZ CABLE AVAILABLE AT THE HOSPITAL, THE SYSTEM WORKED CORRECTLY. ISSUES WERE IDENTIFIED IN THE HANDLE, WHICH WAS BEING USED FOR THE SECOND TIME. THE CLINICIANS REPORTED THAT THE HANDLE PRESENTED EXCESSIVE RESISTANCE WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853485 ↗