AESCULAP
Report
- Report Number
- 2916714-2025-00036
- Event Type
- Injury
- Date Received
- June 20, 2025
- Report Date
- August 12, 2025
- Manufacturer
- AESCULAP INC.
- Product Code
- GEA
- UDI-DI
- 04046964573071
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4) CC 400713732. INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ONE (1) SAMPLE PROVIDED WAS RETURNED TO THE MANUFACTURING SITE FOR TECHNICAL EVALUATION. RESULTS OF THE INVESTIGATION DETERMINED VISUALLY THAT THE SUCTION TUBE SHOWED HEAVY SIGNS OF USE SUCH AS DEEP SCRATCHES AND DINGS. THE INSTRUMENT DID NOT HAVE THE PRODUCTION IDENTIFIERS THAT ARE NORMALLY MARKED ON THE INSTRUMENT. BASED ON THE INVESTIGATION FINDINGS, THE BREAK MOST LIKELY RESULTED FROM HANDLING. AS A RESULT, THE REPORTED FAILURE COULD NOT BE CONFIRMED TO BE A MANUFACTURING RELATED ISSUE.
IT WAS REPORTED TO AESCULAP INC. THAT A FRAZIER SLOT SUCT TUBE ANG 7FR 180MM) PART # MF513R) WAS USED DURING AN ACDF C 4-5, 5-6, 6-7 SOMETIME IN (B)(6) 2024. ACCORDING TO THE COMPLAINANT THE DEVICE SUCTION BROKE AT WELD POINT WHERE SUCTION ATTACHES TO ADAPTER/LUER. REPORTEDLY THE PIECES WERE RETRIEVED AND AN X-RAY WAS PERFORMED TO CONFIRM ALL PIECES WERE REMOVED. A NEW SUCTION WAS OPENED AND USED TO COMPLETE THE PROCEDURE. A TEN-MINUTE DELAY TO THE PROCEDURE WAS ALSO REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746997 | AESCULAP | CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | GEA | AESCULAP INC. | MF513R | 04046964573071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Required Intervention |