AESCULAP JP016Recalls & reported problems
Aesculap AG · PRIMELINE Lid (Outer), Standard 3/4, anthracite, outer length: 463 mm, outer width: 285 mm, outer heigth: 46 mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653354788), received between Oct 5, 2021 and Oct 5, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 5, 2021Fracture; Fracture
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH JP016 - PRIMELINE 3/4 LID ANTHRACITE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE LID CRACKED. ONE LID CRACKED IN THE MIDDLE, AND ANOTHER LID POPPED OFF THE CONTAINER DURING STERILIZATION. THERE WAS A SIGNIFICANT SURGERY DELAY OF 40 MINUTES. STAFF HAD BEEN SETTING UP AND PREPARING FOR A VITRECTOMY PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00644 (400528226 - JP016). 9610612-2021-00645 (400528225 - JP016).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12577681 ↗MalfunctionOct 5, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH JP016 - PRIMELINE 3/4 LID ANTHRACITE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE LID DISCONNECTED. ONE LID CRACKED IN THE MIDDLE, AND ANOTHER LID POPPED OFF THE CONTAINER DURING STERILIZATION. THERE WAS A SIGNIFICANT SURGERY DELAY OF 40 MINUTES. STAFF HAD BEEN SETTING UP AND PREPARING FOR A VITRECTOMY PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00645 (400528225 - JP016).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12577672 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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