MAUDE Adverse Event Report: FEHLING INSTRUMENTS GMBH CERAMO-S RONDO MICRO VESSEL SCISSORS; MICRO SCISSORS

Model Number	BSI-6S
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 observed on the device, in addition to the information provided by the user, suggests that the tip likely broke off due to external forces during the reprocessing.
Event or Problem Description
Broken tip: item returned to the or from aemp with a broken tip.

• Brand Name: CERAMO-S RONDO MICRO VESSEL SCISSORS
• Common Device Name: MICRO 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: anna misterek ; seligenstaedter str. 100; karlstein, 63791 ; GM 63791
• MDR Report Key: 24637425
• Report Number: 3001286223-2026-00004
• Device Sequence Number: 21272417
• Product Code: DWS
• UDI-Device Identifier: 04058749009590
• UDI-Public: 4058749009590
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• 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: BSI-6S
• Device Catalogue Number: BSI-6S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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