MAUDE Adverse Event Report: ETHICON INC. ETHICON SECURESTRAP; STAPLE, IMPLANTABLE

Catalog Number	STRAP25
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 4/7/2026 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.H6 component code: g07002 pending evaluation of returned device additional information was requested ,the following was obtained: product code: (2) strap25 product lot/batch: 103hv9 ; 107jmt 1.Could you please clarify if wrong device belongs to this complaint? 2.If not, could you please clarify if the wrong received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.They may have put the faulty device in the packaging of the new device they opened.The device that was given to me and then sent, was the device they specified did not operate as expected a device has been received, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.The following information was reported: ¿ was the product being used in a clinical trial? no ¿ did the event happen during a procedure? yes ¿ were you in the procedure at the time of the event? no ¿ event outcome/how was it managed? they were able to open a new device and complete procedure ¿ was there any consequence to the patient due to the event? no ¿ has the reporter facility indicated there may be legal action? no.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and absorbable straps were used.After trying to apply the secure strap tacks, the tacks were not able to secure the mesh, they opened another securestrap and the device operated as intended.They were able to open a new device and complete procedure.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 4/21/2026.Corrected information: b1, h1 - additional information was received that this event no longer meets malfunction reporting criteria.This medwatch report is no longer reportable.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.

• 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 ; 3035526892
• MDR Report Key: 24802966
• Report Number: 2210968-2026-03645
• Device Sequence Number: 9537764
• Product Code: GDW
• UDI-Device Identifier: 10705031132993
• UDI-Public: (01)10705031132993(17)260831(10)103HU9
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: 08/31/2026
• Device Catalogue Number: STRAP25
• Device Lot Number: 103HU9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• 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
• Patient Sex: Unknown