n.a. 021299-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551400203), received between Oct 5, 2022 and Oct 5, 2022 — 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 18, 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.

• InjuryOct 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SINGLE-USE STERILE VALVE SEAL WAS INSERTED INTO A LAPAROSCOPIC TROCAR & CANNULA PORT AS A SURGICAL INSTRUMENT FOR LAPAROSCOPIC SURGERY. THE SCRUB NURSES FOUND THE VALVE SEAL WAS BROKEN WITH A MISSING PART AFTER SURGEONS REMOVED THE CANNULA AND RETURNED IT TO THE SCRUB NURSES ON THE TABLE. AS THE BROKEN PIECE OF THE VALVE IS MISSING. INTERNAL REFERENCE NUMBER: (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15546317 ↗
• InjuryOct 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SINGLE-USE STERILE VALVE SEAL WAS INSERTED INTO A LAPAROSCOPIC TROCAR & CANNULA PORT AS A SURGICAL INSTRUMENT FOR LAPAROSCOPIC SURGERY. THE SCRUB NURSES FOUND THE VALVE SEAL WAS BROKEN WITH A MISSING PART AFTER SURGEONS REMOVED THE CANNULA AND RETURNED IT TO THE SCRUB NURSES ON THE TABLE. AS THE BROKEN PIECE OF THE VALVE IS MISSING. INTERNAL REFERENCE NUMBER: (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15546133 ↗