PRIMELINE PRO JP115Recalls & reported problems
Aesculap AG · PRIMELINE PRO Lid (Outer), Standard 3/4, aluminium anodized, silver, outer length: 468 mm, outer width: 294 mm, outer heigth: 37 mm · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964860195), received between Jul 6, 2021 and Jul 6, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Fell” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Fell1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2021Device Fell; Device Fell
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH JP115 - PRIMELINE PRO 3/4 LID SILVER. ACCORDING TO THE COMPLAINT DESCRIPTION, THE LID DROPPED. SET HAD BEEN BROUGHT INTO OPERATING ROOM (OR) TO SET UP FOR SURGERY. WHEN THE SET WAS OPENED, THE PRIMELINE PRO LID TOP DOME PLATE BURST OPEN AND METAL PLATE FROM THE DOME FELL TO THE GROUND. ANOTHER SET WAS USED DUE TO CONCERNS ABOUT STERILITY. THERE WAS NO DESCRIBED PATIENT HARM; THE PATIENT WAS NOT YET IN THE OR. ALL INFORMATION HAS BEEN PROVIDED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12121245 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.