MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CIRCULAR MECH STD 33MM; STAPLE, IMPLANTABLE

Catalog Number	CDH33B
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 5/19/2025 d4 batch #105d60 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 cdh33b device arrived with no apparent damage with the anvil and stapler retainer returned inside a plastic bag.The breakaway washer was present, uncut and the device was fully loaded with staples.Further analysis of the device showed that the trocar was damaged and the anvil could not be reinserted.No functional test was performed due to the condition of the trocar.It is possible that the damage in the trocar caused the adjusting knob issues and closing issue as the anvil could not be inserted properly into the shaft.Additionally, a photo of the packaging was loaded at product complaint level.This defect has been correlated to a manufacturing process.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon endo surgery¿s quality system.A manufacturing record evaluation was performed for the finished device batch number 105d60, and no non-conformances were identified.The lot#133d25 history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: could you please clarify if there were any patient consequences? could you please clarify if there were any change in the post-operative care of the patient as a result of the event?.
Event or Problem Description
It was reported that during a colon resection as soon as the stapler was removed from its box, proceeded to unpack it.When he turned the adjustment knob to separate the anvil stem from the punch¿.It did not open easily as it usually does.The dr.Had to apply a lot of force and finally opened it.In addition, when he tried to turn the knob again, it did not open or close manually.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/21/2025.Additional information was requested, and the following was obtained: 1.Could you please clarify if there were any patient consequences? no, there weren¿t.2.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event? no, there weren¿t.

• Brand Name: CIRCULAR MECH STD 33MM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 22047360
• Report Number: 3005075853-2025-03721
• Device Sequence Number: 18338381
• Product Code: GDW
• UDI-Device Identifier: 10705036003472
• UDI-Public: (01)10705036003472(17)290430(10)133D25
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: CDH33B
• Device Lot Number: 133D25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown