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

Model Number	017619
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2019
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 a pulmonary artery total pneumonectomy resection, the reported device was used for the first firing, but the staples were fired in u shape without being formed in b shape.Another device was used to complete the procedure.The surgical time was extended by less than 30 minutes.There was no patient injury.

• 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: 8300549
• Report Number: 2647580-2019-00658
• Device Sequence Number: 1663177
• Product Code: GDW
• UDI-Device Identifier: 20884521047737
• UDI-Public: 20884521047737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K855047
• 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
• Report Date (Section B): 02/03/2019

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 Expiration Date: 08/31/2021
• Device Model Number: 017619
• Device Catalogue Number: 017619
• Device Lot Number: P6H0728X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1