MAUDE Adverse Event Report: ETHICON, LLC ETHICON SECURESTRAP; STAPLE, IMPLANTABLE

Model Number	OPSTRAP20
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgery, the securestrap was not firing and it was taken out of use, and another device was used.There was not patient harm.

• Brand Name: ETHICON SECURESTRAP
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON, LLC; 475 c street los frailes; industrial park, suite 401; guaynabo PR 00969
• MDR Report Key: 23671403
• Report Number: 23671403
• Device Sequence Number: 18580438
• Product Code: GDW
• UDI-Device Identifier: 10705031231054
• UDI-Public: (01)10705031231054(17)261231(10)105PSK
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025
• Report Date (Section F): 11/14/2025

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: OPSTRAP20
• Device Catalogue Number: OPSTRAP20
• Device Lot Number: 105PSK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Date Report Sent to FDA: 11/14/2025