AESCULAP SR554RRecalls & reported problems
Aesculap AG · Injection Cannula, (370 mm), diam. 5 mm, sharp, luer lock, non-sterile, reusable, to be used with: PG052, PG072SU, PG073SU, SK330C · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653187478), received between Nov 30, 2020 and Nov 30, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2020Break; Break
InjuryNov 30, 2020Break; Break
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SR554R-INJECTION CANNULA SHARP 370MM LL. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED DURING TOTAL LAPAROSCOPIC HYSTERECTOMY THE NEEDLE TIP SUCTION SR554R BROKE OFF IN PATIENT AND REQUIRED A LAPAROTOMY TO RETRIEVE THE TIP. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: Insufficient Information
MAUDE report 10924265 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.