MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE* LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number TLC10

Device Problems Difficult to Insert (1316); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 2/6/2024.D4: batch #117c20.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 revealed that the tlc10 device was received with no apparent damage and with a reload present.The reload was received fully fired with both gripping surfaces broken off, the swing tab area and the deck on the proximal end were noted damaged making the reload nonfunctional.The device was tested for functionality with the test reload and it fired, cut, and formed all the staples as intended.The staple line and cut line were complete, and the staples met the staple form release criteria.The damage on the reload has consisted of an improper loading technique.Please reference the instructions for use for proper cartridge loading.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 117c20, and no non-conformances related to the reported complaint condition were identified.A manufacturing record evaluation was performed for the finished device tlc10 lot number a9ch3m and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure and after firing the tlc10, the surgeon needed another firing, but the scrub nurse was unable to remove the reload as it was stuck onto the stapler.Tried prying it & the wings of the reload broke.Had to open another stapler.There were no patient consequences.

• Type of Device: 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: 18655948
• MDR Text Key: 335951976
• Report Number: 3005075853-2024-01071
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TLC10
• Device Lot Number: A9CH3M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1