AESCULAP PL536RRecalls & reported problems
Aesculap AG · CHALLENGER TI Clip Applier (Shaft Only), multi-fire, (370 mm), diam. 10 mm, to be used with: PL510R, PL569T · 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 04038653241149), received between Oct 29, 2022 and Dec 27, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Unintended Ejection” (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.
Reports received per month
Most reported problems
Device problems
- Unintended Ejection2
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.
InjuryDec 27, 2023Unintended Ejection; Unintended Ejection
IT WAS REPORTED TO AESCULAP INC. THAT A SHAFT COMPL.D:10MM L:370MM (PART# PL536R) WAS USED DURING A BARIATRIC GASTRIC BYPASS ON DECEMBER 06 2023. ACCORDING TO THE COMPLAINANT THE CLIP APPLIER SUCCESSFULLY FIRED AND CLIPPED TWICE. FURTHER USE OF THE CLIP APPLIER CAUSED THE CLIPS TO BACK UP IN CARTRIDGE. REPORTEDLY THE STAFF TRIED AGAIN TO ENGAGE THE CLIP APPLIER AND 3 TITANIUM CLIPS DROPPED INTO THE PATIENT. THE PIECES WERE RETRIEVED DURING SURGERY AND REMOVED FROM INSIDE OF PATIENT. A DELAY OF TWENTY MINUTES WAS REPORTED AS A RESULT OF THIS INCIDENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: (B)(4) (2916714-2023-00125) PL520R, (B)(4) (2916714-2023-00126) PL579T.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18406209 ↗InjuryOct 29, 2022Unintended Ejection; Unintended Ejection
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL536R - SHAFT COMPL.D:10MM L:370MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CARTRIDGE CONTAINER FELL INTO THE PATIENT'S CAVITY INTRAOPERATIVELY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS PL520R - CHALLENGER TI-P HANDLE (9610612-2021-00613) (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15695557 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.