MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. PROXIMATE RELOADABLE LINEAR STAPLER TX60B; STAPLER, SURGICAL

Model Number TX60B

Device Problem Failure to Fire (2610)

Patient Problem Blood Loss (2597)

Event Date 08/01/2018

Event Type  malfunction  

Event Description

Tx60b stapler did not fire, caused bleeding.

• Brand Name: PROXIMATE RELOADABLE LINEAR STAPLER TX60B
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 7809481
• MDR Text Key: 118141752
• Report Number: MW5079349
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: TX60B
• Device Lot Number: R40JOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR