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

Catalog Number	TL90
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8745864
• Report Number: 3005075853-2019-20158
• Device Sequence Number: 19252472
• Product Code: GDW
• UDI-Device Identifier: 10705036013198
• UDI-Public: 10705036013198
• Combination Product (Y/N): N
• Initial Reporter State: CT
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: TL90
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention