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

Catalog Number GST60D

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.

Event Description

It was reported that a crack on the reload was found after cover was opened.No patient consequence reported.

Manufacturer Narrative

(b)(4).Investigation summary: the analysis results showed that one gst60d cartridge reload was received.The reload was received with no apparent damage and fully fired.No functional test could be performed due to the condition of the reload.Event described could not be confirmed as the cartridge was received fully fired and no damaged was noted on the reload.A manufacturing record evaluation was performed for the finished device batch number, 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
• MDR Report Key: 8125726
• MDR Text Key: 129592060
• Report Number: 3005075853-2018-14786
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014690
• UDI-Public: 10705036014690
• Combination Product (y/n): N
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2019
• Device Catalogue Number: GST60D
• Device Lot Number: P4R016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 04/23/2019
• Supplement Dates FDA Received: 05/16/2019
• Patient Sequence Number: 1