MAUDE Adverse Event Report: SMITH AND NEPHEW VERSAJET II EXACT

Lot Number 50691870

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2018

Event Type  malfunction  

Event Description

A (b)(6) underwent laparoscopic revision of a sleeve gastrectomy to a roux-en-y gastric bypass (150 cm roux limb).The smith and nephew versajet was requested by dr.(b)(6).Once connected, the hand piece was determined by dr.(b)(6) to not be functioning properly.A new hand piece was opened and connected and worked properly.

• Brand Name: VERSAJET II EXACT
• Type of Device: VERSAJET II EXACT
• Manufacturer (Section D): SMITH AND NEPHEW; oklahoma city OK
• MDR Report Key: 7334227
• MDR Text Key: 102367941
• Report Number: MW5075821
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2019
• Device Lot Number: 50691870
• 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: 65 YR
• Patient Weight: 100