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

Model Number	017617
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a lobectomy, the device did a poor staple formation.The laparoscopic procedure was then converted to an open due to the device problem.Staple line was over sewed.They changed the stapler for a new one to complete the case.Patient is alive.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received with the pushers advanced and the handle was not locked.Three unformed staples were remaining in the jaws.The approximation handle was in the closed position.Functionally, the instrument was reloaded with staples and applied to test media.The staple line was properly formed, and the jaw properly clamped and unclamped when the approximating lever was operated.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Replication of the observed condition may occur when the firing stroke is not completed during 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.

• Brand Name: ROTICULATOR
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 6907596
• Report Number: 2647580-2017-06937
• Device Sequence Number: 18959084
• Product Code: GDW
• UDI-Device Identifier: 10884521047723
• UDI-Public: 10884521047723
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K855047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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: 017617
• Device Catalogue Number: 017617
• Device Lot Number: P2K0323X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 03/09/2018
• 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: Other; Required Intervention