MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ILA; STAPLE, IMPLANTABLE

Model Number	3948
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during sub total gastrectomy, they used instrument and the reload.The surgeon started firing the device, however the firing stopped at the last 1cm of the line.They replaced by new reload, and connected it to the same instrument, however they could not fire the device at all.Then they replaced by new instrument and another new reload, and the device worked fine.The surgical time was extended by less than 30 min.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: the product sample or additional supporting materials from the account was not available for this incident.A definitive root cause could not be determined with regard to the reported condition.Post market vigilance will continue to monitor this condition for future potential action.Should new information become available, the file will be reopened, and the investigation will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ILA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7789767
• Report Number: 2647580-2018-04109
• Device Sequence Number: 2446449
• Product Code: GDW
• UDI-Device Identifier: 10884521063150
• UDI-Public: 10884521063150
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K885047
• 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
• Report Date (Section B): 02/15/2019

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 Model Number: 3948
• Device Catalogue Number: 3948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1