MAUDE Adverse Event Report: Ethicon Inc. ETHICON SECURESTRAP; Staple, Implantable

Catalog Number	STRAP25R
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and absorbable straps were used.The product clip unable to stay in position.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/30/2026.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3: investigational summary: the product was returned to eth for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the strap25r device was returned with no apparent damage.In addition, the foil packaging was returned along with the instrument.In an attempt to replicate the reported incident, the device was manually activated; however, during subsequent actuations, no straps were deployed despite multiple firing attempts.The instrument was subsequently disassembled for further evaluation.Upon internal inspection, the fork prongs were found to be deformed, preventing proper advancement and deployment of the straps.Additionally, twelve (12) straps were observed remaining within the cannula shaft.The deformed fork prongs are considered the most likely cause of the reported firing failure.The event reported was confirmed and it is related to improper use of the device.A possible cause for the condition of the prongs of the fork deformed is indicative of the device being fired into bone or another hard surface, thus rendering device unusable.A minimum tissue thickness of 6.7 mm is required when applying the fastener over underlying bone, vessels, or viscera.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: ETHICON SECURESTRAP
• Common Device Name: Staple, Implantable
• Manufacturer (Section D): Ethicon Inc.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): Ethicon Inc.-Juarez; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50945845
• Report Number: 2210968-2026-09917
• Device Sequence Number: 13149649
• Product Code: GDW
• UDI-Device Identifier: 10705031470552
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K093845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial

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 Catalogue Number: STRAP25R
• Device Lot Number: 10AZ7R
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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
• Patient Sex: Unknown