MAUDE Adverse Event Report: COVIDIEN VSTEP REP STD RAD EXP SLV W5-12M VSEALPL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number VSR100812P

Device Problems Detachment Of Device Component (1104); Mechanical Jam (2983); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: during a total lap gastrectomy: when removing gauze from an abdominal cavity through the trocar by grasping with forceps, it seemed to be stuck.Then, seal system parts were decomposed by rotating.Dr.Found that packing part of the instrument had been detached.Opened another.Operating time not extended.No tissue damage.Nothing fell into the cavity.No bleeding.No further incident.The last known patient status: good.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation one device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends and an evaluation of the returned device.The reported condition for this incident states that when the device was inserted into the abdominal cavity, it was not inflated.Opened another.Visual and functional testing of the returned sample confirmed the product did not meet quality release specifications that were tested regarding the reported condition due to the disengaged white seal.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.There were no adverse patient events reported as a result of the alleged event.Should new information become available, the file will be re-opened and reassessed at that time.

• Brand Name: VSTEP REP STD RAD EXP SLV W5-12M VSEALPL
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5031415
• MDR Text Key: 25017384
• Report Number: 9612501-2015-00514
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: VSR100812P
• Device Catalogue Number: VSR100812P
• Device Lot Number: J5A0701X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1