MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITANIUM STAPLER; STAPLE, IMPLANTABLE

Catalog Number TL90

Device Problems Failure to Deliver (2338); Activation, Positioning or Separation Problem (2906)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Date of event: month and day unknown.Only year (2019) is known.Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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 surgical procedure was performed? can you please confirm the product code and/or lot number of the device? were there any difficulties experienced with the device intraoperatively? what anatomical structure the device was fired on? what cartridge/color was used for the firing? where in the controlled tissue compression scale was the indicator placed? was the device closed and repositioned? was the staple line inspected prior to dividing the tissue? were there staples noted intraoperatively? if so, were there any issues with staple formation? please describe.How many times was the device fired? on which firing did the issue occur? how was the post-operative bleeding identified? what was the total estimated blood loss (ml)? was a transfusion required? what was done during the reoperation? what is the current status of the patient?.

Event Description

It was reported that the surgeon said that after he fired the stapler he went to open the stapler by ¿pressing the button on the back¿.Surgical procedure was a ¿large abdominal case¿.The stapler was fired on the pancreas.No issues were noted in regards to staple form in the initial surgical procedure.Surgeon believes that the staples never fired and that the compression may have held the tissue together intraoperatively.It is unknown if the device was fired previously in the procedure.The procedure was completed and the patient went to icu.Patient presented with bleeding and came back to the or for reoperation.Surgeon reviewed the line in the reop and alleges there were not staples in the area where it was used.

• 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: 8745864
• MDR Text Key: 149561531
• Report Number: 3005075853-2019-20158
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036013198
• UDI-Public: 10705036013198
• Combination Product (y/n): N
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TL90
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention