MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. CARTRIDGE FINAL ASSY 45MM GREEN; STAPLE, IMPLANTABLE

Catalog Number	CECR45G
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent: 5/1/2025 d4: batch # unk an analysis of the product could not be performed since a physical sample was not received for evaluation.The manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional information was requested.To date, a response has not been received.Should further details become available, a supplemental report will be submitted.Was a leak test performed? if so, what type and what was the result? was the staple line visualized endoscopically during the initial surgical procedure? were there any issues experienced with the device in the initial surgical procedure? does the surgeon believe the post-operative air-leak was related to an alleged deficiency of the device or were there other contributing patient factors? please explain.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.
Event or Problem Description
It was reported that on the afternoon of the second day after surgery, the patient complained of bubble overflow in water-sealed bottle when coughing, which was considered to be lung wound leakage, and the air leakage was aggravated gradually, which was considered to be poor nailing of occluder.The symptoms were improved after intrathoracic infusion of high glucose, and there was still a small amount of air leakage.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/13/2025.Additional information was requested and the following was obtained: was a leak test performed? if so, what type and what was the result? yes.No leak noted.Was the staple line visualized endoscopically during the initial surgical procedure? unknown.Were there any issues experienced with the device in the initial surgical procedure? no.Does the surgeon believe the post-operative air-leak was related to an alleged deficiency of the device or were their other contributing patient factors? the surgeon just guessed it might be related to malformed staples.
Additional Manufacturer Narrative
(b)(4) date sent: 6/11/2025.Additional information was requested and the following was obtained: event date should be 27-mar-2025.

• Brand Name: CARTRIDGE FINAL ASSY 45MM GREEN
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer (Section G): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.; suzhou 21512 6; CH 215126
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21945997
• Report Number: 3005075853-2025-03288
• Device Sequence Number: 8691639
• Product Code: GDW
• UDI-Device Identifier: 10705036001744
• UDI-Public: (01)10705036001744(17)270311(10)E24030010
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: 20080035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CECR45G
• Device Lot Number: E24030010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 05/19/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/13/2025; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male