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

Model Number GPS36

Device Problems Crack (1135); Failure to Align (2522); Material Twisted/Bent (2981)

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

Event Date 06/12/2015

Event Type  malfunction  

Event Description

Procedure: sleeve gastrectomy pre op diagnosis: morbid obesity anatomy involved: stomach, esophagus according to the reporter: anesthesia applied suction and pulled back sail until reaching black line.However, sail didn't go back into groove all the way.Anes.Pulled back harder and we heard a crack and sail still didn't retract all the way.Anes.Took off suction and doctor manually pushed sail into track.Anes.Pulled again and heard another crack.There was no patient injury.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was not delayed by more than 30 minutes.No device fragment fell into the patient.While inserting sail in beginning of case, anes.Struggled a little.Anes.May have twisted device a little which could have affected alignment.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account without.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, engineering review of the product and an evaluation of the returned device.The device functioned as designed.This device was coiled in the packed upon receipt.Even through these thermoplastics took a set in the return package, the device was capable of deploying and retracting completely.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: 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: 4863432
• MDR Text Key: 5809762
• Report Number: 1219930-2015-00493
• 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: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: GPS36
• Device Catalogue Number: GPS36
• Device Lot Number: E5D0001X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1