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

Model Number	3971
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, at the first firing for proximal pancreaticoduodenectomy, the surgeon started firing the device, however could not advance the firing knob on the halfway.Replaced by new cartridge and started firing, however the same event occurred on the halfway.The procedure was completed by using another device.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.The sulu (single used loading unit) was partially fired.Functional testing included loading sulu into a pmv test unit.The instrument and sulu were applied to the appropriate test media with acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer's quality release specifications at the time of manufacture.Replication of the reported condition may occur if the firing stroke is not complete and the firing knob is not fully retracted after firing or if the instrument is applied against an excessive amount of tissue during the clinical application.Our instructions for use warn against the action that was taken.Should new information become available, the file will be re-opened and the investigation summary 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: 7039047
• Report Number: 2647580-2017-07847
• Device Sequence Number: 16421235
• Product Code: GDW
• UDI-Device Identifier: 20884521063164
• UDI-Public: 20884521063164
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K885222
• 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): 02/06/2018

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: 02/28/2022
• Device Model Number: 3971
• Device Catalogue Number: 3971
• Device Lot Number: P7B1124X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1