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

Model Number GST60B

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Three photos were received: the 1st photo shows a tyvek with lot number r40160 of cartridge gst60b.The 2nd photo shows a blue cartridge gst60b and inside the package, the pan can be seen partially dislodged on the left side.The 3rd photo shows a blue cartridge outside of the package with the pan partially dislodged and a loose driver was observed.Based on the photos reviewed, the event described is confirmed, however, no conclusion or root cause could be determined.

Event Description

It was reported that during a hemicolectomy, the surgeon opened the load in the surgical field, and when the scrub nurse tried to place the load on the echelon rail, it could not be placed because the load was defective.There were no patient consequences reported.

Manufacturer Narrative

(b)(4) date sent: 7/2/2020 d4: batch #r59c75 investigation summary the analysis results showed that one gst60b cartridge reload was returned unfired with eight double drivers and two single drivers missing, making the reload non-functional.In addition, the cartridge pan was noted to be partially dislodged from left proximal side.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.No conclusion could be reached on what may have caused the cartridge pan to dislodge.In addition, it should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.

• Brand Name: GST BLUE RELOAD, 60MM, 6 ROW
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9953415
• MDR Text Key: 200027946
• Report Number: 3005075853-2020-02144
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014706
• UDI-Public: 10705036014706
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2023
• Device Model Number: GST60B
• Device Catalogue Number: GST60B
• Device Lot Number: R40160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Date Manufacturer Received: 06/04/2020
• Patient Sequence Number: 1