MAUDE Adverse Event Report: FEHLING INSTRUMENTS GMBH CERAMO RONDO TORLOCK NON-TRAUM.MICRO FORCEPS

Model Number	COD-1T
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Intraoperative Cardiac Injury (4855)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This is a fine micro-forceps used in surgery.The teeth of the working part at the distal end are damaged.The last tooth of the single row of teeth is bent distally and partially torn away from the base material.Furthermore, the surface of the teeth at the affected point is partially deformed and exposed bare metal.Intraoperative finding: upon palpation of the heart muscle, a tear in the tissue with bleeding occurred.No further information is available.
Additional Manufacturer Narrative
The teeth of the working part at the distal end are damaged.The last tooth of the single row of teeth is bent distally and partially torn away from the base material.Furthermore, the surface of the teeth at the affected point is partially deformed and exposed bare metal.The batch history was checked and it didn't show any deviations.Our reprocessing instruction states the following: visually inspect for damage and wear using a magnifying lamp.Pay particular attention to critical points on moving parts and in the work area.Defective, damaged instruments whose label is no longer legible must be sorted out and cleaned and disinfected before being returned to the manufacturer.Re-pairs may only be carried out by the manufacturer or workshops authorized.

• Brand Name: CERAMO RONDO TORLOCK NON-TRAUM.MICRO FORCEPS
• Common Device Name: MICRO FORCEPS
• Manufacturer (Section D): FEHLING INSTRUMENTS GMBH; seligenstädter str. 100; karlstein, bavaria 63791 ; GM 63791
• Manufacturer (Section G): FEHLING INSTRUMENTS GMBH; seligenstädter str. 100; karlstein, bavaria 63791 ; GM 63791
• Manufacturer Contact: esther bauer ; seligenstädter str. 100; karlstein, bavaria 63791 ; GM 63791
• MDR Report Key: 24617402
• Report Number: 3001286223-2026-00001
• Device Sequence Number: 9834238
• Product Code: DWS
• UDI-Device Identifier: 04058749121391
• UDI-Public: 04058749121391
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: COD-1T
• Device Catalogue Number: COD-1T
• Device Lot Number: 905643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 5 KG