MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG GASTRISAIL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	GPS36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter: occurred post-operatively following a laparoscopic sleeve gastrectomy.The stomach was resected using the gastric positioning system.An additional operation was performed due to the formation of a stricture.To correct the issue, the sleeved stomach was dilated.Surgical intervention was necessary to prevent a permanent impairment of a function.The event lead to or extended patient hospitalization.An additional operation will be performed to correct the issue.Patient status is alive, no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The problem was observed for 1 week post-op.Patient is still vomiting once per week and is having a liquid diet.The dilation of the sleeved stomach will be performed to correct the issue.There was no unanticipated tissue loss.
Additional Manufacturer Narrative
Corrected information: sex.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GASTRISAIL
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6643004
• Report Number: 1219930-2017-05810
• Device Sequence Number: 707277
• Product Code: KNT
• UDI-Device Identifier: 20884521517377
• UDI-Public: 20884521517377
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K143088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: GPS36
• Device Catalogue Number: GPS36
• Device Lot Number: E6K0019X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 08/09/2017; 08/09/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 09/07/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention