MAUDE Adverse Event Report: Katalyst Surgical, LLC 27ga Slim DEX¿ EZPeel Forceps; FORCEPS, OPHTHALMIC

Model Number	DVFO4037-27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in a complaint that the tine of forceps broke off.
Additional Manufacturer Narrative
Product was returned for investigation.The broken area was observed to be frayed and splintered, consistent with repeated back-and-forth bending.This type of damage typically occurs when the instrument is struck against a surface and the tines are subsequently manipulated back to their original position, causing the metal to splinter.

• Brand Name: 27ga Slim DEX¿ EZPeel 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: 50237259
• Report Number: 3007589150-2026-00019
• Device Sequence Number: 16045768
• Product Code: HNR
• UDI-Device Identifier: 10840096212966
• UDI-Public: 10840096212966
• 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): 08/13/2026

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: DVFO4037-27
• Device Catalogue Number: DVFO4037-27
• Device Lot Number: M45497
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/08/2025
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2024
• 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