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

Catalog Number	CDH33B
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior resection the device misfired.
Additional Manufacturer Narrative
(b)(4).Date sent 4/22/2025.D4 batch #u5ax9l.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 along with the anvil inside a plastic bag and the shaft of the anvil returned damaged (bent).The anvil lock spring was in good condition and the trocar had some scratches.It is possible that the scratches on the trocar were caused trying to insert the anvil.Only one staple was present protruding in the pocket and the breakaway washer was uncut and it had a mark.Upon visual inspection a slight damage was found on the guide face in the same area than washer.Also, the safety had scratches.It appears that an attempt was made to fire the device with the safety engaged.It should be notice that to fire the device, draw the red safety back toward the adjusting knob until it seats into the body of the device.If the safety cannot be released, the device is not in the safe firing range.The device was reloaded with staples and tested for functionality with a test anvil and a test washer; the device formed all the staples, as well as completely cut the test media and the breakaway washer without incident.The staple line was complete and the staples meet the staple form release criteria.No conclusion could be reached on what caused the damage of the anvil.The condition of the washer indicates that the device had not been fired through a full firing stroke, the orange indicator was not fully into the safe green firing range or the anvil was not reattached correctly.It should be noted that before firing, ensure that the orange indicator is fully within the green range of the gap setting scale and the anvil is reattached correctly.To reattach the detachable head or anvil do not clamp across or grip on the locking springs as it might not click into place.Not reattaching the anvil correctly or the orange indicator not being set on the green range will result in a bigger gap between the anvil and the guide face, therefore the staples will not hit the anvil to make b- formed staples.In addition, if the firing sequence is not complete, staples could be partially deployed without cutting the washer.Please reference the instructions for use for additional information.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number u5ax9l, and no non-conformances were identified.The lot/batch 913c39 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: was the firing sequence started but not completed? if yes: did the device deliver any staples? if yes, were the staples formed properly? what was the appearance of the deployed staples (b-formed, malformed, goal post/legs straight)? if yes, was the staple line complete? was the backlight lit? is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event?.
Additional Manufacturer Narrative
(b)(4) date sent: 6/9/2025 corrected data: b1, h1.H11.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• 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: 21881634
• Report Number: 3005075853-2025-02832
• Device Sequence Number: 18335050
• Product Code: GDW
• UDI-Device Identifier: 10705036003472
• UDI-Public: (01)10705036003472(17)250228(10)913C39
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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 Expiration Date: 02/28/2025
• Device Catalogue Number: CDH33B
• Device Lot Number: 913C39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2020
• 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