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

Catalog Number	CR40G
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 12/10/2024.D4 batch #505a32.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 some 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.A manufacturing record evaluation was performed for the finished device batch number 505a32, and no non-conformances were identified.Additional information was requested, and the following was obtained: 1.Please provide more details of device malfunction.2.Did the device cut ¿ no.3.If the device cut/fired, was the cut line complete.4.Did the device staple - no.5.If the device stapled/fired, was the staple line complete - no.6.If the device stapled, was the shape of the staples (b-formation, irregular, unformed)? 7.Did the device close - no.8.Did the device fire - no.9.Did the device open - yes.10.Was the device difficult to close on the tissue - yes.11.Was the device difficult to fire - yes.12.Was the device difficult to open - no.13.On which firing did this occur ¿ first.14.Did the tissue retaining pin lock into the correct position - no.15.Could you please clarify if there were any patient consequences - no.16.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event - no.
Event or Problem Description
It was reported that during an unknown procedure the device was not working.

• 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 ; * ; 3035526892
• MDR Report Key: 20891955
• Report Number: 3005075853-2024-09327
• Device Sequence Number: 18402981
• Product Code: GDW
• UDI-Device Identifier: 10705036001430
• UDI-Public: (01)10705036001430(17)260930(10)505A32
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 12/10/2024

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: 09/30/2026
• Device Catalogue Number: CR40G
• Device Lot Number: 505A32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• 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