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

Catalog Number	STRAP12
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Additional information was requested and the following was provided: - were there any patient consequences? the patient's condition is stable.- was there any associated medical or surgical intervention to treat any of the patient consequences? if so, please clarify.The bleeding site was stopped by an electric knife.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a laparoscopic unknown surgery on an unknown date and absorbable straps were used.The device (100tp8) did not deploy straps at the 1st firing, and half of the clip was ejected at first the 2nd firing.One clip popped out when an air shot with the device outside of the surgical field.The device (100esa) also did not deploy straps at the 1st firing, and the clip was adhering to the upper abdominal wall.It could not be fixed to the abdominal wall at the 1st firing, but it was confirmed that there was bleeding from the site where it was hit.The bleeding site was stopped by an electric knife.The grasping force of both devices was higher than expected.A competitive device was used as a replacement.Two devices will be returning.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Additional information: h4.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Additional information: h3, h6.H3 investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the strap12 device was returned with no apparent damage in the external components and a petri dish with one(1) straps inside.In addition, a foil pouch was received.Upon cycling, the instrument was noted to be empty and locked out.For fire testing the trigger was unblocked and functional test was conducted successfully, the device worked as intended.The device was disassembled and no straps were found inside cannula shaft.No abnormalities were noted on internal device components.The provided device was fully dispensed.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21307120
• Report Number: 2210968-2025-01348
• Device Sequence Number: 20838134
• Product Code: GDW
• UDI-Device Identifier: 10705031132986
• UDI-Public: (01)10705031132986(17)260331(10)100ESA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: 03/31/2026
• Device Catalogue Number: STRAP12
• Device Lot Number: 100ESA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/05/2025; 02/05/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/28/2025; 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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