MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC.; STAPLE, IMPLANTABLE

Catalog Number	CDH29B
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the staples came out of the clamp before use, requiring a change of clamp.
Additional Manufacturer Narrative
(b)(4).Date sent 8/26/2026.D4 batch # 844d36.Investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the cdh29b device arrived with no apparent damage without stapler retainer.Further analysis on the device shows one staple was missing from the pockets and the breakaway washer was uncut in the anvil.No functional test was performed in order to preserve the evidence.In addition, a tyvek returned along with the device.No conclusion could be reached on what cause the staple to fell out.It should be noted that all devices are inspected 100% for staple presence by an automated vision system and are visually inspected 100% as a final check.In addition, at finished goods the devices are visually inspected based on a sample.A manufacturing record evaluation was performed for the finished device batch number 844d36, and no non-conformances were identified.Additional information was requested, and the following was obtained: was there a patient consequence? if yes, how was the issue addressed? could you please clarify if there were any change in the post-operative care of the patient as a result of the event? no patient consequences are to be deplored on this case, the stapler was changed before use, however causing an overconsumption and a waste of time for the team.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50453712
• Report Number: 3005075853-2026-07108
• Device Sequence Number: 9644849
• Product Code: GDW
• UDI-Device Identifier: 10705036003465
• UDI-Public: (01)10705036003465(17)301130(10)854D57
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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 Catalogue Number: CDH29B
• Device Lot Number: 854D57
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2025
• 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