MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON GASTRISAIL 36 FR. GASTRIC POS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number GPS36

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Anatomy involved: stomach according to the reporter: sail did not fully retract into the main tube and was transected by the idrive stapler with a egia60amt sulu on the 3rd firing.The sail came to a hard stop and the black line showed completely over the top of the handle, so it was not determined that it was cut until attempting to remove from the patient.The device was cut away at the point where it was stapled into the stomach.The gastrotomy was repaired with another firing the egia60amt.They were able to insert a 36f bougie and restaple this area making it smaller.It may be possible that there was not enough traction on the greater curve when the sail was retracted into the main tube, causing the mucosa to get caught between the sail and the slot in the main tube.This could have caused the sail to bow out and get caught in the jaws of the stapler.The current patient status is good.It is not thought currently by the surgeon that the patient will have a stricture etc.The patient stayed one extra day and is doing good now.No trauma reported after her upper gi.There was unanticipated tissue loss as a result of this problem.There was no blood loss.Of over 500cc.The surgical time was extended over 30 minutes.30 minutes due to the product problem? yes a) was any adverse event reported as a result of any delay in surgery? (i.E.An extension of the hospital stay, infection, etc.?) unknown 5.What is the current status of the patient? unknown ***additional information from jackie koonce on 8/13/2015***i was on the phone with the sales rep this am.He states the tube was stapled to the sail and they had to pull the staples out of the sail.They were able to insert a 36f bougie and restaple this area making it smaller.It is not thought currently by the surgeon that the patient will have a stricture etc.The patient stayed one extra day and is doing good now.No trauma reported after her upper gi.

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of received 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 device was received with the distal end of the sail severed.Staples were noted on the cut end of the sail.Engineering determined that the device was deployed in the stomach and the surgical team failed to retract the sail prior to stapling with the powered stapler and tissue reinforcement.The surgeon stapled through the sail due to not retracting it.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.Should new information become available, the file will be re-opened and reassessed at that time.

• Brand Name: GASTRISAIL 36 FR. GASTRIC POS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5027720
• MDR Text Key: 23944726
• Report Number: 1219930-2015-00769
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Followup,Followup
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: GPS36
• Device Catalogue Number: GPS36
• Device Lot Number: E5E0004X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention