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

Model Number	3971
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The single use loading unit (sulu) was received partially applied.The sulu was loaded 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 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.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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.
Event or Problem Description
According to the reporter, during sub total gastrectomy, they opened the package and tried to connect cartridge to device, however they noticed the staples of the proximal end came out of the staple pockets.They stopped using this cartridge and replaced by the new cartridge, now the firing is complete.The event occurred during the procedure but the product was not used for patient.Patient there was no patient injury.

• 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: 7322061
• Report Number: 2647580-2018-01245
• Device Sequence Number: 120219
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

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: 05/31/2022
• Device Model Number: 3971
• Device Catalogue Number: 3971
• Device Lot Number: P7E0389X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1