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

Catalog Number GST60B

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Batch number =p5756y.The analysis results showed that one gst60b reload was received fully fired, with the pan detached from the cartridge.While no conclusion could be reached on what caused the pan to dislodged.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.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during a laparoscopic gastrectomy, the cartridge pan was left inside the jaws when the cartridge was removed after the first firing.The device was used on duodenum.Another device was used to complete the case.There were no adverse consequences to the patient.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7182764
• MDR Text Key: 97067179
• Report Number: 3005075853-2018-07231
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036014703
• UDI-Public: 20705036014703
• Combination Product (y/n): N
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2020
• Device Catalogue Number: GST60B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1