AESCULAP FF013PRecalls & reported problems
Aesculap AG · SCALPFIX STERILE · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653221875), received between Dec 11, 2023 and Dec 11, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2023Material Fragmentation; Insufficient Device Problem Information; Material Fragmentation; Insufficient Device Problem Information
IT WAS REPORTED TO AESCULAP INC. THAT A SCALPFIX STERILE (PART# FF013P) WAS USED DURING A SHUNT PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SURGEON ACCIDENTALLY LEFT THE CLIP INSIDE THE PATIENT AFTER CLOSING THE SCALP. AN X-RAY WAS TAKEN. IT IS NOT CURRENTLY KNOW IF ANY FURTHER INTERVENTION HAS BEEN, OR WILL BE PERFORMED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 18305961 ↗
Other CLIP, SCALP devices
- CODMAN® 201037Integra Lifesciences Production Corporation · CLIP, SCALP1 recall4 reports
- NA CM8902Medtronic Ps Medical, Inc. · CLIP, SCALP1 recall0 reports
- WECK IPN028499Teleflex Incorporated · CLIP, SCALP2 reports
- CODMAN 20-1037Cerenovus, Inc. · CLIP, SCALP2 reports
- CODMAN® 201038Integra Lifesciences Production Corporation · CLIP, SCALP1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.