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

Catalog Number GST60T

Device Problems Failure to Advance (2524); Failure to Form Staple (2579); Failure to Fire (2610)

Patient Problem No Code Available (3191)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Batch # unk.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.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.Additional information requested and received: is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event (extended hospital stay, readmission, re-operation, etc.)? i have spoken with the surgeon regarding this and the patient had a prolonged air leak post op.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.What were the indications for surgery? what stapler was being used? approximately how far did device fire? were any higher than usual forces (to fire or close) or unusual sounds noticed? does the surgeon believe that the difficulties experienced with device is related to air leak? what is the current patient status?.

Event Description

It was reported that the device was being used for a lung resections.The staple was loading into the stapler and fired.The device stopped firing half way and the knife blade would not proceed.The reverse button was used to return the knife blade and open the stapler.The staples had not formed correctly.A new reload was opened and loaded into the same device to complete the procedure.

Manufacturer Narrative

Product complaint #: (b)(4).Batch # p57u1z.Investigation summary: the analysis results showed that one gst60t cartridge reload was received.The reload was received with no apparent damage and fully fired.As the returned reload was received 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: GST BLACK RELOAD, 60MM, 6 ROW
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8658639
• MDR Text Key: 146663907
• Report Number: 3005075853-2019-19429
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014720
• UDI-Public: 10705036014720
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2022
• Device Catalogue Number: GST60T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 06/12/2019
• Supplement Dates FDA Received: 06/19/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention