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

Model Number GST60D

Device Problem Unintended Ejection (1234)

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

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 5/26/2023.Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a laparoscopic procedure, the cartridge was loose and came off from the psee60a before use.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 6/27/2023.D4: batch # 968a54.Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that one gst60d reload was received partially fired.The returned reload was reset and loaded into a test device.The device was tested for functionality in the straight position and achieved its complete stroke firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples meet the staple form release criteria.The reload was loaded into the device without difficulties and did not fall out during the visual and functional testing.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond indicated thickness.This may have prevented the top of the knife blade assembly from entering into the anvil.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 968a54, and no non-conformances were identified.

• Brand Name: GST GOLD RELOAD, 60MM, 6 ROW
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17010193
• MDR Text Key: 316512999
• Report Number: 3005075853-2023-03561
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014690
• UDI-Public: 10705036014690
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110385
• 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,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GST60D
• Device Catalogue Number: GST60D
• Device Lot Number: 174C61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1