MAUDE Adverse Event Report: Katalyst Surgical, LLC 27ga DEX¿ Stiff Super Grip II Forceps; FORCEPS, OPHTHALMIC

Model Number	DVF4036-27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in the complaint that the tips of the forceps have broken off.
Additional Manufacturer Narrative
The returned product was evaluated and received with both forceps tines fractured.Investigation found damage consistent with the use of an improperly fitting tip protector.The resulting damage may have weakened the forceps tips, making them susceptible to fracture during unpacking, surgical setup, or use.The exact cause of the reported event could not be conclusively determined.

• Brand Name: 27ga DEX¿ Stiff Super Grip II Forceps
• Common Device Name: FORCEPS, OPHTHALMIC
• Manufacturer (Section D): Katalyst Surgical, LLC; 722 goddard avenue; cehsterfield 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: 50229728
• Report Number: 3007589150-2026-00012
• Device Sequence Number: 10273675
• Product Code: HNR
• UDI-Device Identifier: 10840096202608
• UDI-Public: 10840096202608
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: DVF4036-27
• Device Catalogue Number: DVF4036-27
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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