MAUDE Adverse Event Report: FEHLING INSTRUMENTS GMBH CERAMO TC HYP.VASCULAR SCISSORS

Model Number	BOP-7
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The health professional reported the problem 6 months after the problem occured.We've started the investigation immediately after receiving all necessary information and tried to submit the report via esgnextgen.As the submission wasn't successful, we've contacted the support team and sent the form 3500a via e-mail.
Event or Problem Description
On (b)(6) 2025 we received a complaint that the tips of 3 scissors (ref: bop-7) were broken.The scissors have been used for more than a year.The scissors are reusable instruments and need to be reprocessed after each use.The tip of one scissors (ref: bop-7) seems to be broken during surgery, but we don't know, which of the 3 scissors is subject to this report.We received the following information from our customer: the surgeon discovered the damage on one of the scissors during a case while the instrument was inside the patient.She insists that the blade broke inside the patient.She paused the surgery and used a c-arm x-ray machine to search for the blade fragment in the patient, but she never found the fragment and the patient is still alive with no complications as far as we know.On request, we received this additional information from our customer: assist states that they had been using the scissors throughout the case.When the surgeon used them to cut into a coronary artery, the scissors looked intact going into the arterial lumen.When the scissors were withdrawn, the tip was missing.The arterial lumen was flushed several times and the surgical area inspected.An x-ray was subsequently taken.No foreign body was detected on imaging.Remark: as the tip wasn't found in the patient or in the or, it could have been broken outside the or.These scissors are delicate and tips might break during reprocessing.

• Brand Name: CERAMO TC HYP.VASCULAR SCISSORS
• Common Device Name: VASCULAR SCISSORS
• Manufacturer (Section D): FEHLING INSTRUMENTS GMBH; hanauer landstr. 7a; karlstein, bavaria 63791 ; GM 63791
• Manufacturer (Section G): FEHLING INSTRUMENTS GMBH; hanauer landstr. 7a; karlstein, bavaria 63791 ; GM 63791
• Manufacturer Contact: esther bauer ; hanauer landstr. 7a; karlstein, bavaria 63791 ; GM 63791
• MDR Report Key: 22735448
• Report Number: 3001286223-2025-00001
• Device Sequence Number: 9104340
• Product Code: LRW
• UDI-Device Identifier: 04058749007237
• UDI-Public: 4058749007237
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BOP-7
• Device Catalogue Number: BOP-7
• Device Lot Number: 20224691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown