MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. RELOAD- CURVED CUTTER STAPLER; STAPLE, IMPLANTABLE

Catalog Number	CR40G
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	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/23/2024.D4: batch #362c44.B3: only event year known: 2023.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample determined that the cr40g reload was received with all staples protruding, the washer uncut and with the knife recessed below the reload deck.The drivers were noted to be partially advance.No functional test was performed due to the condition of the reload.The condition of the reload is consistent with the device being partially activated.As a result of the partial firing the lockout was engaged when the device was reopened.Do not fire the instrument unless the closure trigger is properly latched against the handle.The firing trigger must be pulled back completely against the closure trigger to properly fire the instrument.In addition, if the firing sequence is not complete, you could deploy the staples without cutting the washer and forming the staples.Please reference instructions for use for additional information.It should be noted that as part of our quality process al devices are manufactured, inspected, and released to approved specifications.Additionally, a photo was provided and it showed the condition of the reported event.A manufacturing record evaluation was performed for the finished device batch number 362c44, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device cr40g lot number u40d17 and no non-conformances were identified.Additional information was requested, and the following was obtained: 1.There was no patient consequences because the surgeon change into new cartridge to apply to the patient.It worked well.2.There was to patient problem at all.
Event or Problem Description
It was reported that during an unknown procedure the nurse installed the cartridge and removed the safety lock, but the stapler was sticking out of the groove by about 1mm.The stapler was removed, replaced with a new product, and surgery was performed.The operating room nurse said that unlike before, other contour cartridges felt stiff when installed.

• Brand Name: RELOAD- CURVED CUTTER STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18772906
• Report Number: 3005075853-2024-01599
• Device Sequence Number: 17258753
• Product Code: GDW
• UDI-Device Identifier: 10705036001430
• UDI-Public: 10705036001430
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K040038
• 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
• Report Date (Section B): 02/23/2024

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: 04/30/2025
• Device Catalogue Number: CR40G
• Device Lot Number: U40D17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2020
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown