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

Model Number	GPS36
Medical Device Problem Codes	Difficult To Position (1467); Difficult to Remove (1528); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter, during a lap gastrectomy, the crna placed the device with cm markings to the patient left but minutes later when the surgeon instructed her to deploy the sail, the tube appeared to deploy to the greater curves rather that the lighted sail.So, the sail was retracted and the crna attempted to rotate the main tube to the 9:00 position and redeploy the sail.But, it was visually obvious that the distal end did not look correct.So, she attempted to retract the sail completely but was unable to get up to the black indicator line.She then was instructed by the surgeon to remove the entire device.She was unable to remove device completely due to resistance.She then used a laryngoscope to aid in viewing the distal end of the device still in the back of the throat.She was able to free it and remove the device.The lighted sail had been tied in a knot while in the patient.There was no patient injury.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account.The sail was deployed and knotted around the tubing.Replication of the reported condition may be due to rough handling of the device.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: GASTRISAIL 36 FR. GASTRIC POS
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• MDR Report Key: 5783269
• Report Number: 1219930-2016-00720
• Device Sequence Number: 587395
• Product Code: KNT
• UDI-Device Identifier: 10884521517370
• UDI-Public: (01)10884521517370(1)011700(10)E6B0003GX
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K143088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: GPS36
• Device Catalogue Number: GPS36
• Device Lot Number: E6B0003GX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2016
• Supplement Report FDA Received Date: 03/13/2017
• Patient Sequence Number: 1
• Patient Age: 24 YR