30977 See Sharp - Enhanced Intraoperative Laparoscope Cleaning & DefoggingRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00787551037029), received between Aug 20, 2021 and Aug 27, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2021Detachment of Device or Device Component

  DURING LAPAROSCOPIC CASE, BLUE, PLASTIC PART OF TAMPON PORTION OF THE SEE SHARP (REF 30977) WAS SCRAPED UPON ENTRY INTO TROCAR. THE PLASTIC SCRAPING ACTUALLY CAME OFF AND ONTO THE FIELD. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12384908 ↗
• MalfunctionAug 20, 2021Flaked

  TAMPON OR TROCAR CLEANING DEVICE WHEN PLACED IN TROCAR THE PLASTIC FLAKED OFF TAMPON BUT THE FLAKES WERE RETRIEVED FROM TROCAR. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12353998 ↗