MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE ENDO TA; STAPLE, IMPLANTABLE

Model Number	010901
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2018
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 open nephrectomy procedure, while the device was being used to staple the vessels, the device was unable to fire and had poor staple formation.They also saw few pushing bars came up.They took a new loading to resolve the issue and complete the case.No patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The visual inspection and functional evaluation of the device had acceptable results.A review of the device history record could not be performed because the lot number was not provided.However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MULTIFIRE ENDO TA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7385381
• Report Number: 2647580-2018-01664
• Device Sequence Number: 19180584
• Product Code: GDW
• UDI-Device Identifier: 20884521047768
• UDI-Public: 20884521047768
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K910192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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: 07/31/2022
• Device Model Number: 010901
• Device Catalogue Number: 010901
• Device Lot Number: P7G1398MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1