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

Model Number	DVFO4037-25-S
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction

• Brand Name: 25ga Stiff 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: 50168147
• Report Number: 3007589150-2026-00006
• Device Sequence Number: 5305184
• Product Code: HNR
• UDI-Device Identifier: 10840096212928
• UDI-Public: 10840096212928
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• 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 Expiration Date: 02/16/2025
• Device Model Number: DVFO4037-25-S
• Device Catalogue Number: DVFO4037-25-S
• Device Lot Number: M31346
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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