MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GST GREEN RELOAD, 60MM, 6 ROW; STAPLE, IMPLANTABLE

Catalog Number GST60G

Device Problems Failure to Cut (2587); Separation Problem (4043)

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

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 12/11/2023.D4: batch # 305c89.Investigation summary.The product was returned to ethicon endo-surgery for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample revealed that one gst60g reload was returned inside its package unopened; upon visual inspection, green foreign matter were noted to be inside the packaging.During manufacturing/testing in some cases, component friction can result in small shavings ejecting from the reload after packaging during transit.In addition, damage to the reload was noted on the knife channel.No functional test was performed due to the condition of the reload.This defect has been correlated to a manufacturing process.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon endo surgery¿s quality system.A manufacturing record evaluation was performed for the finished device batch number 305c89, and no non-conformances were identified.

Event Description

It was reported that the gst60g reload first firing to create the sleeve at the antrum using a psee60a powered echelon stapler.After first firing at the antrum the stomach tissue was difficult to tease away from the stapler.Surgeon reported that in his experience the tissue usually falls away when the jaws are opened but in this instant it did not.He noted a long stringy piece of? mucosa hanging from the anvil and using a grasper he was able to free the stringy tissue and transected stomach from it from the anvil.The staple line was then examined and found to be intact with no oozing evident.Two further subsequent thick tissue firings with gst60g had the same tissue sticking to anvil jaw but easily removed using a grasper.After stepping down to gold reloads gst60d for the remainder of the sleeve without incident a leak test was performed and was negative for the presence of any leaks.No patient consequences reported.No further information is available.

• Brand Name: GST GREEN RELOAD, 60MM, 6 ROW
• 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 ; * ; 3035526892
• MDR Report Key: 18300595
• MDR Text Key: 330163138
• Report Number: 3005075853-2023-09234
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014713
• UDI-Public: 10705036014713
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GST60G
• Device Lot Number: 349C64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1