MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. RELOADS FOR LINEAR CUTTERS; STAPLE, IMPLANTABLE

Catalog Number	6R45B
Medical Device Problem Code	Material Integrity Problem (2978)
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: 6/3/2024.D4: batch # u5aw31.B3: only event month and day known.Year is unknown but assumed to be the year that the complaint was reported.Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection was conducted on the return reload.Visual analysis of the returned sample revealed that the 6r45b reload was received with the cartridge pan and body of the reload bent and damaged.Also, the spring cartridge, 3 double drivers and 1 single driver were loose inside a plastic bag.The damage to the reload is consistent with the device being clamped over a hard object.To mitigate the potential for staples getting into the reload and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and reload jaw in sterile solution and then wipe the anvil and reload jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.Please reference the instruction for use for more 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 u5aw31, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure that when the reload was opened it was noticed that it was broken.Another reload was opened to continue with the procedure.There were no adverse consequences for the patient.

• Brand Name: RELOADS FOR LINEAR CUTTERS
• 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 ; *
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19449495
• Report Number: 3005075853-2024-04029
• Device Sequence Number: 14262869
• Product Code: GDW
• UDI-Device Identifier: 10705036000846
• UDI-Public: 10705036000846
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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: 02/28/2025
• Device Catalogue Number: 6R45B
• Device Lot Number: U40746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown