MAUDE Adverse Event Report: Katalyst Surgical, LLC 25ga DEX¿ Stiff Hassan Forceps; FORCEPS, OPHTHALMIC

Model Number	DVF4035-25
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in the complaint that the inner wire came out during use.
Additional Manufacturer Narrative
The returned product was evaluated, and the wire/tip was found completely separated from the device and returned separately attached to the protector.The hypotube was also returned empty.The investigation could not determine when the set screw became loose; however, based on the available information, it is suspected that loosening likely occurred after quality control inspection, potentially during cleaning or packaging.

• Brand Name: 25ga DEX¿ Stiff Hassan Forceps
• Common Device Name: FORCEPS, OPHTHALMIC
• Manufacturer (Section D): Katalyst Surgical, LLC; 722 goddard avenue; chesterfield MO 63005
• Manufacturer (Section G): Katalyst Surgical, LLC; 722 goddard avenue; chesterfield MO 63005
• Manufacturer Contact: meryl wilhelm ; 722 goddard avenue,; chesterfield, MO 63005 ; +1(636)536-5950
• MDR Report Key: 50180855
• Report Number: 3007589150-2026-00010
• Device Sequence Number: 9880390
• Product Code: HNR
• UDI-Device Identifier: 10817489027155
• UDI-Public: 10817489027155
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: DVF4035-25
• Device Catalogue Number: DVF4035-25
• Device Lot Number: M41934
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/02/2024
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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