MAUDE Adverse Event Report: ETHICON ENDO-SURGERY 1 PROXIMATE; LINEAR STAPLER

Model Number TX60B

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/23/2017

Event Type  malfunction  

Event Description

A piece of the ethicon endo-surgery 1 proximate reloadable linear stapler tx60b cartridge broke off when the stapler was fired.The broken portion was immediately retrieved.This did not appear to affect the staple line, and no immediate injury to the patient was observed.

• Brand Name: 1 PROXIMATE
• Type of Device: LINEAR STAPLER
• Manufacturer (Section D): ETHICON ENDO-SURGERY; guaynabo PR 00969
• MDR Report Key: 6975820
• MDR Text Key: 90321165
• Report Number: MW5072938
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: TX60B
• Device Catalogue Number: TX60B
• Device Lot Number: P4RW6L
• Was Device Available for Evaluation?: Yes
• 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 Age: 30 YR