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

Model Number	BOP-9
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The damage to the shears indicates that excessive force was applied.The distributor suspects that the damage occurred during processing.The exact circumstances and the serial number in question are unclear.
Event or Problem Description
A distributor informed us that a customer claimed that some of the damaged scissor blades were discovered in the or but before they had been used inside the patient.The surgeon discovered the damage on one of the scissors (the distributor doesn't know which one) during a case while the instrument was inside the patient.The surgeon insists that the blade broke inside the patient.The surgeon 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 the distributor knows.It is suspected that all these instruments were damaged due to improper handling outside of the operating room, and it was simply unfortunate timing that the damage was not discovered before the surgery.

• Brand Name: CERAMO TC HYP.VASCULAR SCISSORS
• Common Device Name: SCISSORS
• Manufacturer (Section D): FEHLING INSTRUMENTS GMBH; seligenstaedter str. 100; karlstein, 63791 ; GM 63791
• Manufacturer (Section G): FEHLING INSTRUMENTS GMBH; seligenstaedter str. 100; karlstein, 63791 ; GM 63791
• Manufacturer Contact: alia czyrt ; seligenstaedter str. 100; karlstein, 63791 ; GM 63791
• MDR Report Key: 24637218
• Report Number: 3001286223-2026-00003
• Device Sequence Number: 18602416
• Product Code: LRW
• UDI-Device Identifier: 04058749007251
• UDI-Public: 4058749007251
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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-9
• Device Catalogue Number: BOP-9
• 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: 06/26/2025
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• 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