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

Model Number	STRAP25
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Device misfired.

• 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: 50801917
• Report Number: 50801917
• Device Sequence Number: 8643700
• Product Code: GDW
• UDI-Device Identifier: 10705031132993
• UDI-Public: (01)10705031132993
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/02/2026
• Report Date (Section F): 09/02/2026

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: STRAP25
• Device Catalogue Number: STRAP25
• Device Lot Number: 10ddbq
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 238 LB
• Date Report Sent to FDA: 09/02/2026