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

Catalog Number	TL90
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.Maude report mw5075375.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.In what surgical procedure was the device used? on what anatomical structure was the device used? were there any staple formation issues identified during the care of the patient? where in the gap setting scale was the indicator prior to firing? what was the date of the initial surgery? what was the date of the reoperation? how long after the initial surgery was leak identified? were the other known potential causes of anastomotic leaks considered or ruled out? what is the current patient status?.
Event or Problem Description
It was reported that during an ileostomy procedure, the surgeon experienced an anastomotic leak.The patient was getting septic; returned to operating room for re-exploration.Upon re-exploration, leakage was noted from the device's staple line.Ileostomy closure.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7416760
• Report Number: 3005075853-2018-09055
• Device Sequence Number: 70438
• Product Code: GDW
• UDI-Device Identifier: 20705036013195
• UDI-Public: 20705036013195
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/10/2018
• 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