MAUDE Adverse Event Report: ETHICON ETHICON TL90; STAPLER

Catalog Number TL90

Device Problem Fluid/Blood Leak (1250)

Patient Problems Failure to Anastomose (1028); Sepsis (2067)

Event Date 01/31/2018

Event Type  Injury  

Event Description

Used tl90 stapler to close ileostomy on (b)(6) 2018.Pt was getting septic; returned to operating room for re-exploration on (b)(6) 2018.Upon re-exploration, leakage was noted from tl90 staple line.

• Brand Name: ETHICON TL90
• Type of Device: STAPLER
• Manufacturer (Section D): ETHICON; guaynabo PR 00969
• MDR Report Key: 7285589
• MDR Text Key: 100692104
• Report Number: MW5075375
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TL90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 80 YR
• Patient Weight: 50